NA 317.62Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587038636), received between Aug 30, 2021 and Sep 2, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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. 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.

• MalfunctionSep 2, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5 DRILL BIT/UNIV-HALL 12 STOP/44.5. THIS REPORT IS 10 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416219 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5 DRILL BIT/UNIV-HALL 12 STOP/44.5 THIS REPORT IS 9 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410600 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5 DRILL BIT/UNIV-HALL 12 STOP/44.5. THIS REPORT IS 8 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410595 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5 DRILL BIT/UNIV-HALL 12 STOP/44.5. THIS REPORT IS 3 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410579 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/UNIVERSAL-HALL WITH 12MM TOP/44.5MM. THIS REPORT IS 1 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388744 ↗

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