NA 05.001.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982128362), received between Dec 18, 2017 and Apr 9, 2018 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CABLE DEVICE WAS OUT OF ORDER. 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 7406525 ↗
• MalfunctionDec 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS EVENT 3 OF 6 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED MAXILLOFACIAL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ELECTRIC PEN DRIVE (EPD) DEVICE WAS CONNECTED BY CABLE DEVICE TO THE CONSOLE DEVICE PRIOR TO USE. ACCORDING TO THE REPORTER, THE PEN DRIVE DEVICE BECAME SO HOT THAT IT BURNED A HOLE THROUGH HIS STERILE ROBE AND SCRUBS. THE SURGEON AND PATIENT WERE NOT HURT IN ANY WAY, HOWEVER, THE SURGEON DID HAVE TO GET SCRUBBED AGAIN. IT WAS ALSO OBSERVED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS NOT WORKING PROPERLY, SEEMING TO GET STUCK WHEN USING A RASP DEVICE AND RECIPROCATING SAW BLADE DEVICE. THE COMPANY REPRESENTATIVE TRIED TO RUN THE EPD SET BUT COULD NOT REPLICATE THE PROBLEM. THE USER TRIED RUNNING THE ATTACHMENT DEVICE WITHOUT ANY CUTTER WHILE CONNECTED TO THE PEN DRIVE AND IT CONTINUED TO SPIN EVEN THOUGH THE DEVICE WAS COMPLETELY DISCONNECTED. IT CONTINUED SPINNING AND MAKING A WHIRRING SOUND FOR AT LEAST THIRTY SECONDS. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125922 ↗

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