NA 05.001.120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982129345), received between Dec 11, 2017 and Sep 16, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Device Reprocessing Problem; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793839 ↗
• MalfunctionFeb 25, 2025Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED THAT WHEN THE DRILL ATTACHMENT WITH CHUCK DEVICE WAS CONNECTED TO THE HANDPIECE, IT WAS OBSERVED THAT THE DEVICE DID NOT OPERATE AND OVERHEATED RAPIDLY. ACCORDING TO THE REPORTER, DURING THIS OCCURRENCE, THE TEMPERATURE OF THE HANDPIECE ITSELF REMAINED WITHIN NORMAL LIMITS, INDICATING THAT THE HANDPIECE WAS FUNCTIONING PROPERLY. IT WAS REPORTED THAT WHEN DIFFERENT ATTACHMENTS WERE CONNECTED TO THE HANDPIECE DEVICE, THEY OPERATED NORMALLY WITHOUT ANY ISSUES AND THEREFORE, IT CAN BE CONCLUDED THAT THERE WERE NO PROBLEMS WITH THE HANDPIECE ITSELF. 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 2025. 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 21456693 ↗
• MalfunctionAug 12, 2024Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE DRILL ATTACHMENT WITH JACOBS CHUCK 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 19963072 ↗
• MalfunctionSep 11, 2023Excessive Heating; Excessive Heating

  THIS IS EVENT 1 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 17718905 ↗
• MalfunctionApr 27, 2023Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED BY HUNGARY THAT DURING POST-SURGERY, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE WITH CHUCK MADE A STRANGE NOISE AND OVERHEATED. 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. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. 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 16822163 ↗
• MalfunctionApr 12, 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 ATTACHMENT DEVICE WITH CHUCK WAS WORN, THE ETCHING WAS WORN, THE DEVICE HAD CORROSION/RUSTING/PITTING, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, WAS MAKING EXCESSIVE NOISE, HAD HEAT, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK DRILL CHUCK FUNCTION, CHECK DRILL CHUCK IN SMALLEST RANGE, AND CHECK DRILL CHUCK IN LARGEST RANGE. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT 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 16724425 ↗
• MalfunctionMay 9, 2021Premature Separation; Premature Separation

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE DRILL ATTACHMENT JACOBS CHUCK DEVICE HAD AN UNINTENDED/UNEXPECTED DISENGAGEMENT, AND A WORN COUPLING WITH A COSMETIC DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF TOOL COUPLING. 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. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. 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 11795477 ↗
• MalfunctionMay 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT THE DRILL ATTACHMENT DEVICE BROKE INTO TWO. 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 BUT WAS KNOWN TO HAVE 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 Known Impact Or Consequence To Patient

  MAUDE report 8609004 ↗
• MalfunctionDec 11, 2017Device Stops Intermittently; Device Operates Differently Than Expected; Device Stops Intermittently; Device Operates Differently Than Expected

  THIS IS REPORT 5 OF 5 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ELECTRIC PEN DRIVE DEVICE HAD A BAD CONTACT AND WOULD SOMETIMES STOP WHEN USED WITH THREE ATTACHMENT DEVICES, A HAND SWITCH DEVICE, AND A HANDPIECE DEVICE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT AS AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO 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 7104551 ↗

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