NA 05.001.037Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982128515), received between Dec 7, 2017 and Mar 19, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (12 reports).

6 other recalls cover devices cleared under the same FDA submission (K043310); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Compatibility Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE K-WIRE ATTACHMENT FOR PEN DRIVE DEVICE WAS FRACTURED AND A FRAGMENT REMAINED INSIDE THE DEVICE AND IT WAS IMPOSSIBLE TO REMOVE IT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643224 ↗
• MalfunctionOct 28, 2025Compatibility Problem; Separation Problem; Compatibility Problem; Separation Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE K-WIRE ATTACHMENT FOR PEN DRIVE DEVICE WOULD BREAK/DAMAGE THE K-WIRE DEVICES. IT WAS FURTHER DETERMINED THAT THE DEVICE CANNOT INSERT K-WIRE, LOCKING MECHANISM STIFF/STUCK, AND MISSING COMPONENTS - HANDLE/LEVER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRETEST STEPS: GENERAL CONDITION, CHECK THE VERSION OF THE SLEEVE FOR SPRING, CHECK FUNCTION OF TENSIONING LEVER, AND CHECK CLAMPING RANG ON TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT FEED THE K-WIRE DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406149 ↗
• MalfunctionFeb 5, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR ON THE DEVICE MADE EXCESSIVE NOISE, HEATED UP, COULD NOT SECURE/DRIVE K-WIRE, THE COUPLING COULD NOT ENGAGE THE ATTACHMENT, THE ETCHING WAS ILLEGIBLE AND DOES NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR MARKING AND LABELING, CHECK FUNCTION OF TENSIONING LEVER, CHECK CLAMPING RANG ON TOOL COUPLING AND FUNCTION TEST IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315469 ↗
• MalfunctionAug 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM AUSTRALIA THAT THE K-WIRE ATTACHMENT DEVICE HAD METAL PIECES COMING OUT EVERY TIME IT WAS USED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074493 ↗
• MalfunctionAug 13, 2024Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE K-WIRE ATTACHMENT DEVICE BEARING MADE NOISE AND WAS HEATING UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975422 ↗
• MalfunctionAug 12, 2024Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE K-WIRE ATTACHMENT DEVICE HAD NOISY BEARINGS AND WAS HEATING UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962740 ↗
• MalfunctionAug 12, 2024Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE K-WIRE ATTACHMENT DEVICE WAS HEATING UP AND THE BEARING WAS MAKING NOISE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962645 ↗
• MalfunctionNov 15, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 5 OF 5 FOR THE SAME EVENT. IT WAS REPORTED FROM AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ONE (X1) HANDPIECE DEVICE AND FOUR (X4)ATTACHMENT DEVICES WERE HEATING UP AND VERY HOT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140661 ↗
• MalfunctionSep 11, 2023Physical Resistance/Sticking; Excessive Heating; Physical Resistance/Sticking; Excessive Heating

  THIS IS EVENT 2 OF 2 OF THE SAME EVENT IT WAS REPORTED FROM INDIA THAT THE DRILL ATTACHMENT DEVICE OVERHEATED WHILE IN USE WITH THE ELECTRIC PEN DRIVE DEVICE AND K WIRE DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718901 ↗
• MalfunctionAug 1, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM AUSTRALIA THAT THE ATTACHMENT DEVICE IS LEAVING METAL FLAKES WHEN K-WIRING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436744 ↗
• MalfunctionJun 13, 2023Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE K WIRE ATTACHMENT DEVICE WAS HEATING UP, MADE EXCESSIVE NOISE, COULD NOT SECURE THE K WIRE AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR CLAMPING RANG ON TOOL COUPLING AND FUNCTION TEST IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116838 ↗
• MalfunctionFeb 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT METAL SHAVINGS WERE COMING OUT OF THE K-WIRE ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452097 ↗
• MalfunctionJan 5, 2023Premature Separation; Premature Separation

  IT WAS REPORTED FROM FRANCE THAT THE ATTACHMENT DEVICE HAD A PIN NOSE THAT WOULD UNSCREW ON ITS OWN. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101603 ↗
• MalfunctionJul 20, 2022Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS WORN, HAD ILLEGIBLE ETCH, THE MOVING PARTS DID NOT MOVE SMOOTHLY, HAD EXCESSIVE NOISE AND HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK FUNCTION OF THE TENSIONING LEVER AND FUNCTION TEST IN THE RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065725 ↗
• MalfunctionJun 14, 2022Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE K-WIRE ATTACHMENT DEVICE HAD A WORN ETCH, WOULD NOT HOLD THE K-WIRE, HAD EXCESSIVE NOISE, HEAT, ILLEGIBLE ETCH AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECK FUNCTION OF THE TENSIONING LEVER, CHECK CLAMPING RANGE ON THE TOOL COUPLING AND FUNCTION TEST IN THE RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684576 ↗
• MalfunctionApr 18, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT THE K-WIRE ATTACHMENT DEVICE OVERHEATED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137482 ↗
• MalfunctionMar 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT THE CLIP TO SECURE AND RELEASE THE WIRE CAME OFF THE K-WIRE ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732989 ↗
• InjuryFeb 2, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE PEN DRIVE DEVICE AND K-WIRE ATTACHMENT DEVICE, WHILE ANCHORING/INSERTING THE NAILS HEATED UP AND BURNED THE PATIENT'S BONE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. MULTIPLE ATTEMPTS FOR FOLLOW-UP HAVE BEEN PERFORMED. IT WAS NOT REPORTED WHAT/IF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Burn(s); Unspecified Tissue Injury

  MAUDE report 13427384 ↗
• InjuryJul 16, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE KIRSHNER WIRE (K-WIRE) ATTACHMENT DEVICE DID NOT ADEQUATELY CATCH THE 'NEEDLE' (WIRE) WHICH CAUSED THE DEVICE TO SLIP AND WAS UNABLE TO BE REMOVED FROM THE BONE. ACCORDING TO THE REPORTER, THE K-WIRE WAS INITIALLY ENGAGED AND IN THE BONE, HOWEVER WHEN TRYING TO REMOVE IT, THE K-WIRE ATTACHMENT DEVICE DISENGAGED AND IT WAS NOT POSSIBLE TO REMOVE THE WIRE. IT WAS REPORTED THAT THIS CAUSED AN 'AFFECTATION' IN THE PATIENT. IT WAS REPORTED THAT THE SURGEON HAD TO PERFORM AN ADDITIONAL INCISION TO REMOVE THE K-WIRE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING A SPARE DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT NO FRAGMENTS WERE LEFT IN THE PATIENT AND THE PATIENT WAS IN GOOD HEALTH. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF PROLONGED HOSPITALIZATION DUE TO THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12184814 ↗
• MalfunctionMay 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM (B)(6) THAT DURING POST SURGERY STERILIZATION, IT WAS OBSERVED THAT THE KIRSCHNER (K) WIRE ATTACHMENT DEVICE WAS LEAKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795501 ↗
• MalfunctionDec 18, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE K-WIRE ATTACHMENT DEVICE OVER HEATED WHILE BEING USED TOGETHER WITH THE ELECTRIC PEN DRIVE DEVICE. IT WAS ALSO REPORTED THAT THE ELECTRIC PEN DRIVE DEVICE WAS NOT WORKING. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037548 ↗
• MalfunctionDec 17, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT THE K-WIRE ATTACHMENT DEVICE WAS GIVING METAL SHAVING OFF THE WIRES. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028280 ↗
• MalfunctionMar 4, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM THE (B)(6) THAT POST PROCEDURE IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS MAKING A STRANGE NOISE AND WAS HEATING UP. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786990 ↗
• MalfunctionNov 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE SEIZED UP WHILE DRILLING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DRIVE SHAFT OF THE DEVICE WAS BROKEN OFF THE PINION CAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384291 ↗
• MalfunctionFeb 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT THE K-WIRE ATTACHMENT DEVICE WAS NOT HOLDING THE WIRES WHILE BEING USED TOGETHER WITH THE DRILL/BURR ATTACHMENT DEVICE, WHICH WAS ALSO NOT HOLDING THE CUTTER DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE PINION CAGE COMPLETE SHAFT HAD BROKEN OFF. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8325877 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043310. One submission often covers many models, so check the product and lot details in each record.

• Z-0681-2017 · Nov 1, 2016 · Terminated
  Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
• Z-2783-2016 · Jun 24, 2016 · Terminated
  Light Adaptor for Small Battery Drive and Small Battery Drive II.
• Z-2784-2016 · Jun 24, 2016 · Terminated
  Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in
• Z-2199-2016 · May 31, 2016 · Terminated
  Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments ar
• Z-1313-2015 · Dec 19, 2014 · Terminated
  Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticati
• Z-0615-2014 · Apr 15, 2013 · Terminated
  Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and met