HWE

Death

4

Injury

448

Malfunction

19,856

Other

2

Total

20,310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K143191 — IntelliSense Drill Mcginley Innovations · 2015-02-20
• K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES Ortho Solutions Limited · 2011-01-20
• K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE The Anspach Effort, Inc. · 2007-01-16
• K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM Zimmer Trabecular · 2005-05-26
• K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM Synthes (Usa) · 2005-01-05
• K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS Medical Device Services · 2002-09-18
• K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS Adven Medical · 2002-02-04
• K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS Adven Medical · 2002-02-04
• K990816 — AVCORE SYSTEM Modular Cutting Systems, Inc. · 1999-09-24
• K973736 — AESCULAP HILAN MOTOR SYSTEM Aesculap, Inc. · 1997-12-29
• K973560 — BONE GRAFT HARVESTER Ds Mfg., Inc. · 1997-11-12
• K972508 — SURGICAL BURS AND SURGICAL DRILL BITS Synvasive Technology, Inc. · 1997-08-26
• K971342 — DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) Disk Whisk, Inc. · 1997-07-08
• K971544 — SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) Synthes (Usa) · 1997-05-28
• K962087 — SERVOTRONIC EC100 SYSTEM Medicon, Inc. · 1997-04-23
• K970088 — RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: Richard Wolf Medical Instruments Corp. · 1997-04-07
• K970023 — MEDNEXT SURGICAL BUR Mednext, Inc. · 1997-02-28
• K970040 — SPINE-TECH BONE HARVESTER Spine-Tech, Inc. · 1997-02-28
• K962913 — SYNTHES STERILE DRILL BITS Synthes (Usa) · 1996-11-14
• K962800 — STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES Stryker Instruments · 1996-09-11
• K962215 — CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER U.S. Medical Products, Inc. · 1996-08-15
• K962022 — POWERCUT GOLD SURGICAL SYSTEM Baxter Healthcare Corp · 1996-08-05
• K961970 — COMMAND 2 MICOELECTRIC SURGICAL SYSTEM Stryker Corp. · 1996-07-26
• K961759 — CEMENT AND BONE REMOVAL KIT Maillefer Instruments S.A. · 1996-06-13
• K960720 — EXACTECH STERILE MODULAR DRILL BIT Exactech, Inc. · 1996-04-23
• K960852 — HALL MODULAR ACETABULAR REAMER SYSTEM Linvatec Corp. · 1996-03-20
• K953968 — AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) Aesculap, Inc. · 1996-02-05
• K955098 — 3M MINI-DRIVER ELECTRIC SYSTEM 3M Company · 1996-01-22
• K955591 — MICROAIRE SMARTDRIVE SYSTEM Microaire Surgical Instruments, Inc. · 1996-01-18
• K952543 — GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET Neoligaments, Ltd. · 1995-06-22
• K950013 — CONSENSUS(TM) ORTHOPEDIC DRILL BIT U.S. Medical Products, Inc. · 1995-05-05
• K946197 — CONSENSUS(TM) PATELLA REAMER U.S. Medical Products, Inc. · 1995-04-05
• K944946 — CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER U.S. Medical Products, Inc. · 1995-02-01
• K945186 — CONSENUS HIP SYSTEM -- ACETABULAR REAMER U.S. Medical Products, Inc. · 1995-01-27
• K945189 — CONSENSUS HIP SYSTEM -- CALCAR PLANER U.S. Medical Products, Inc. · 1995-01-27
• K945208 — CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER U.S. Medical Products, Inc. · 1995-01-27
• K943589 — STRYKER TOTAL PERFORMANCE SYSTEM Stryker Corp. · 1994-12-15
• K942108 — COHORT BONE BRUSH Advanced Med/Surg, Inc. · 1994-10-11
• K942956 — SURGICAL INSTRUMENTS AND ACCESSORIES Stryker Corp. · 1994-09-23
• K942660 — HALL MICROCHOICE ELECTRIC POWERED SYSTEM Hall Surgical, Division of Zimmer, Inc. · 1994-09-07
• K932918 — TOTAL KNEE KIT Biodynamic Technologies, Inc. · 1994-09-01
• K931429 — COOL CUT Mitab · 1994-04-29
• K935753 — THE GRAFTOLOGER Neoligaments, Ltd. · 1994-04-25
• K931734 — INTERMEDICS ORTHOPEDICS DRILL BITS Intermedics Orthopedics · 1994-02-22
• K935322 — SNAP BONE REAMER Surgiquip, Inc. · 1994-01-28
• K935516 — SNAP DRILL Surgiquip, Inc. · 1994-01-27
• K931176 — BONE SAW BLADES Betzler Mfg., Inc. · 1994-01-26
• K932699 — ARTHREX AR-8200 SHAVER SYSTEM Arthrex, Inc. · 1994-01-25
• K935567 — SODEM POWER SYSTEM Sodemsystems · 1994-01-21
• K930319 — OSTEON ADAPTOR/CRADLE United American Medical Co., Inc. · 1994-01-07
• K930363 — POWERED SURGICAL INSTRUMENT ACCESSORY Intenn Engineering, Inc. · 1994-01-07
• K931837 — ACUFEX STERILE DRILLS Acufex Microsurgical, Inc. · 1994-01-07
• K932261 — ES-100 ACCESSORIES Elekta Instruments, Inc. · 1994-01-07
• K922056 — HHI ELECTRIC CONSOLE #875-000 H&H Instruments · 1992-09-18
• K921131 — CKS OSCILLATING SAW BLADE Techmedica, Inc. · 1992-06-08
• K911929 — SMALL BONE FIXATION SYSTEM United American Medical Co., Inc. · 1991-07-02
• K911930 — STERILE PACKAGED POWER INSTRUMENT ACCESSORIES United American Medical Co., Inc. · 1991-07-02
• K902525 — ACE/WILLIAMS MICROSURGERY SAW SYSTEM Buckman Co., Inc. · 1990-11-26
• K903650 — OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 Micro-Aire Surgical Instruments, Inc. · 1990-09-14
• K902447 — CORING NEEDLE (TREPHINE, ORTHOPEDIC) Biomedtrix, Ltd. · 1990-08-14
• K902332 — HALL MODULAR ACETABULAR REAMER SYSTEM Zimmer, Inc. · 1990-06-25
• K901165 — MODULAR FLEXIBLE DRILLING SYSTEM Dalton Technology, Inc. · 1990-06-13
• K895198 — HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM Zimmer, Inc. · 1989-09-15
• K882008 — ACE SCREW REMOVAL TREPHINE Buckman Co., Inc. · 1988-06-10
• K880150 — PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM Dyonics, Inc. · 1988-03-04
• K874044 — INTRA-ARTICULAR ARTHROSCOPIC SHAVER Medline Industries, Inc. · 1987-10-15
• K871717 — MODEL 28200C MICRO-ARTHROPLASTY SYSTEM KARL STORZ Endoscopy-America, Inc. · 1987-06-05
• K864929 — HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST Hall Surgical, Division of Zimmer, Inc. · 1987-01-28
• K855216 — 3M ARTHROSCOPIC SURGICAL SYSTEM 3M Company · 1986-03-04
• K854987 — INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM Richard Wolf Medical Instruments Corp. · 1986-02-11
• K853376 — MORGAN SUTURE-DRILL Bowen & Company, Inc. · 1985-11-13
• K853489 — DEXTRA PRECISION POWER SYSTEM Chattanooga Group, Inc. · 1985-09-30
• K833940 — TORQUE PLUS CATALOG 30120 Concept, Inc. · 1983-12-28
• K802105 — C-BLADE Cutter Laboratories, Inc. · 1980-09-16
• K792353 — INTRA-ARTICULATED EDGER-PLANER SYSTEM Richard Wolf Medical Instruments Corp. · 1979-12-27
• K760977 — CHARNLEY FEMUR DRILL #1 AND #2 Codman & Shurtleff, Inc. · 1976-11-16