NA 05.001.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982128324), received between Nov 29, 2017 and Sep 17, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (1 report).

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

• InjurySep 17, 2019Overheating of Device; Overheating of Device

  THIS IS REPORT 4 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 9078433 ↗
• MalfunctionApr 12, 2018Device Inoperable; Device Inoperable

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ELECTRIC PEN DRIVE DEVICE AND CABLE DEVICE STOPPED WORKING WHILE IN USE TOGETHER. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 7424667 ↗
• MalfunctionDec 11, 2017Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CUTTING BURR DEVICE BROKE WHILE OPENING THE SUTURE HOLE FOR A DURAL LIFT. IT WAS REPORTED THAT THE EVENT OCCURRED DURING USE ON A PATIENT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PIECES OF THE BROKEN DEVICE WERE RETRIEVED FROM THE PATIENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 7105308 ↗
• MalfunctionDec 11, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT CABLE DEVICE HAD AN UNDETERMINED MALFUNCTION. IT WAS REPORTED THAT THE ELECTRIC PEN DRIVE DEVICE WAS WORKING ON AND OFF WHEN IT WAS USED WITH THE DEVICE. IT WAS REPORTED THAT THE EVENT OCCURRED DURING USE ON A PATIENT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7104687 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CABLE DEVICE WAS NOT WORKING. IT WAS NOT REPORTED IF THERE WERE ANY NO DELAYS TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE AND THE SURGICAL PROCEDURE WAS COMPLETED. 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 Consequences Or Impact To Patient

  MAUDE report 7067604 ↗

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