NA 05.001.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982128447), received between Mar 2, 2018 and Feb 11, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Excessive Heating

  IT WAS REPORTED THAT J-LATCH ATTACHMENT COUPLING DEVICE WAS OVERHEATING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, 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 NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. 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 24312709 ↗
• MalfunctionMay 4, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT THE COUPLING DEVICE WAS OVERHEATING. 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 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278495 ↗
• MalfunctionFeb 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM (B)(6) THAT THE ATTACHMENT LATCH COUPLING FOR THE ELECTRIC PEN DRIVE DEVICE WAS LEAKING OIL WHILE IN USE WITH THE SHORT AND MEDIUM ATTACHMENT DEVICES. 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 13451358 ↗
• InjurySep 17, 2019Overheating of Device; Overheating of Device

  THIS IS REPORT 1 OF 4 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ¿PLUG¿ WAS STUCK IN THE HANDPIECE DEVICE WHILE BEING USED TOGETHER WITH THE DRILL ATTACHMENT J-LATCH COUPLING DEVICE, DRILL/BURR ATTACHMENT DEVICE, AND CABLE DEVICE. ACCORDING TO THE REPORTER, THE ISSUE WAS OBSERVED SEVERAL TIMES DURING PRE-SURGERY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD TO BE HOSPITALIZED LONGER DUE TO A BURNT LIP (INFECTION AND PAIN) WHICH RESULTED IN SWELLING AND POST-SURGICAL PAIN. THERE WAS A FIFTEEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WAS MEDICAL INTERVENTION AND PROLONGED HOSPITALIZATION ASSOCIATED WITH THIS EVENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Burn(s); Pain; Unspecified Infection

  MAUDE report 9078426 ↗
• MalfunctionMar 2, 2018Unintended System Motion; Fail-Safe Problem; Unintended System Motion; Fail-Safe Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT A SNAP RING OF THE OF THE DRILL ATTACHMENT DEVICE BECAME LOOSE, MAKING IT POSSIBLE FOR THE BEARINGS TO SHIFT AND COMPRESS THE GEARBOX. IT WAS FURTHER DETERMINED THAT THE LACK OF LUBRICATION ALSO CONTRIBUTED TO THE FAILING OF THE DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OF FREE MOVING AND FUNCTION TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7309453 ↗

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-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-2783-2016 · Jun 24, 2016 · Terminated
  Light Adaptor for Small Battery Drive and Small Battery Drive II.
• 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