NA 05.001.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982128164), received between Dec 8, 2017 and Dec 27, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Electrical /Electronic Property Problem; Unintended Electrical Shock; Electrical /Electronic Property Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD THE FOLLOWING FAILURES: WILL NOT RUN - ELECTRICAL CONTROL UNIT DAMAGED AND ELECTRIC SHOCK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST ON THE FOLLOWING: SAFETY TEST / ELECTRICAL LEAKAGE CURRENT CHECK. 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 UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026985 ↗
• MalfunctionJul 15, 2022Fire; Environmental Particulates; Appropriate Device Problem Term/Code Not Available; Excessive Heating; Fire; Environmental Particulates; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED THAT THE CONSOLE DEVICE CAUGHT FIRE AND WAS SMOKING. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE 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 NOT REPORTED. 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 15030827 ↗
• MalfunctionJun 24, 2022Device Alarm System; Break; Complete Loss of Power; Unintended Electrical Shock; Device Alarm System; Break; Complete Loss of Power; Unintended Electrical Shock

  IT WAS REPORTED FROM REUNION THAT THE BASE CONSOLE DEVICE NO LONGER WORKS AND THE LED NO LONGER LIGHTS UP. IT WAS ALSO REPORTED THAT THE COVER WAS BROKEN (SHOCK OR FALL OF THE 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 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. 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 14802194 ↗
• InjuryNov 20, 2020Excessive Heating; Excessive Heating

  THIS IS REPORT 3 OF 5 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT 2 ELECTRIC PEN DRIVE DEVICES, A CONSOLE DEVICE, AND 2 ATTACHMENT DEVICES OVERHEATED. IT WAS REPORTED THAT CLINICAL ENGINEERING DID A PRELIMINARY TEST AND GRINDING NOISES WERE HEARD. IT WAS REPORTED THAT THERE WAS PATIENT INJURY, HOWEVER THE EXTENT OF THE INJURY WAS UNKNOWN. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. IT IS UNKNOWN IF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Burn(s); Injury

  MAUDE report 10876458 ↗
• InjuryFeb 15, 2018Device Emits Odor; Device Inoperable; Noise, Audible; Device Emits Odor; Device Inoperable; Noise, Audible

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT AN ODOR GENERATED FROM THE CONSOLE DEVICE WHILE ITS MOTOR WAS GENERATING A ROTATION SOUND. IT WAS FURTHER REPORTED THAT THE POWER LAMP WAS NOT ILLUMINATED ON THE DEVICE. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN THE SURGEON TURNED ON THE DEVICE. AS A RESULT, THE SURGEON STOPPED THE SURGERY; AND ORDERED AN ALTERNATIVE CONSOLE DEVICE AND A POWER CABLE DEVICE. IT WAS REPORTED THAT WHILE WAITING FOR THE ALTERNATIVE DEVICES, THE PATIENT WORE OFF GENERAL ANESTHESIA. IT WAS REPORTED THAT ONCE THE ALTERNATIVE DEVICES WERE RECEIVED, THE PATIENT WAS GIVEN A GENERAL ANESTHESIA AGAIN; AND THE SURGERY WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS A DELAY TO THE SURGICAL PROCEDURE; HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. 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 7273922 ↗
• MalfunctionDec 8, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION OF THE SCAPHOID BONE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CONSOLE DEVICE WOULD NOT STAY ON. THERE WAS AN EIGHT MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7098897 ↗

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