NA 05.001.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982128430), received between Feb 13, 2020 and Dec 26, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 26, 2025Excessive Heating; Excessive Heating

  THIS IS REPORT 3 OF 3 OF THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ELECTRIC PEN DRIVE DEVICE BURNED A PATIENT DURING USE. IT WAS REPORTED THAT THE DEVICE WAS USED WITH RECIPROCATING SAW AND DRILL ATTACHMENT DEVICES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. PATIENT INVOLVEMENT AND INJURY WERE REPORTED. HOWEVER, IT IS UNCLEAR WHETHER ANY MEDICAL INTERVENTION WAS PROVIDED OR IF PROLONGED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Burn(s)

  MAUDE report 23896110 ↗
• MalfunctionDec 20, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM AUSTRALIA THAT THE ELECTRIC PEN DRIVE DEVICE, ATTACHMENT DEVICE, HAND SWITCH DEVICE AND CABLE DEVICE WERE OVERHEATING AND GETTING HOT TO HOLD. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF SPARE DEVICES WERE AVAILABLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18368472 ↗
• MalfunctionNov 15, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 4 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 18140664 ↗
• MalfunctionJul 13, 2023Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED BY THE NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DRILL ATTACHMENT DEVICE PRODUCED HEAT AND DID NOT FUNCTION. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315225 ↗
• MalfunctionApr 26, 2021Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD COMPONENT DAMAGE AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR UNTRUE RUNNING. 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 11725380 ↗
• MalfunctionFeb 23, 2021Device Reprocessing Problem; Leak/Splash; Mechanical Jam; Device Reprocessing Problem; Leak/Splash; Mechanical Jam

  IT WAS REPORTED THAT THE DRILL ATTACHMENT DEVICE WAS NOT FUNCTIONING IN THE FORWARD SETTING AND HAD BLACK RESIDUE LEAKING OUT OF THE CONNECTING HALF OF THE TIP. 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 11368591 ↗
• MalfunctionAug 19, 2020Vibration; Vibration

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT DRILL ATTACHMENT DEVICE HAD VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE TOOL COUPLING AND CHECK FOR UNTRUE RUNNING. 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 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425854 ↗
• MalfunctionApr 2, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD CUTTER WHIP, EXCESSIVE UNTRUE RUNNING AND THE INABILITY TO DRILL PROPERLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR UNTRUE RUNNING AND FUNCTION TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE MOTOR DEVICE HAD WORKED INTERMITTENTLY WITH ATTACHMENTS. 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 Consequences Or Impact To Patient

  MAUDE report 9916932 ↗
• MalfunctionFeb 13, 2020Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD VIBRATION AND FAILED PRE-TEST FOR UNTRUE RUNNING. 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 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 9706259 ↗

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