NA 317.78Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587038728), received between Aug 31, 2018 and Oct 28, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionOct 28, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE DRILL BIT SNAPPED AFTER DRILLING FOR SCREW PLACEMENT. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC WITH 8MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711621 ↗
• MalfunctionNov 6, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR BONE (BONE DRILLING) PIERCING SURGERY. DURING THE SURGERY, THE DRILL WAS BROKEN OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/MINI QC WITH 8MM STOP/44.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10803585 ↗
• InjuryJun 17, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING MAXILLOFACIAL SURGERY FOR FACIAL TRAUMA (MANDIBLE), WHILE DRILLING FOR SHARPS TO INSERT SCREWS, THE TWO (2) DRILL BITS BROKE WITHOUT THE POSSIBILITY OF RECOVERING THE FRAGMENTS. THERE WAS SURGICAL DELAY OF TWENTY (20) MINUTES. SURGERY WAS COMPLETED BY CHANGING THE DRILL BITS. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC WITH 8MM STOP/44.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10165436 ↗
• InjuryJun 8, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING FACIAL TRAUMA MAXILLOFACIAL SURGERY THAT TWO DRILL BITS BROKE. FRAGMENTS WERE GENERATED. FRAGMENTS OF ONE DRILL BIT WERE RECOVERED. FRAGMENTS FROM THE SECOND DRILL BIT WERE NOT SUCCESSFULLY RECOVERED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO KNOWN PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/MINI QC WITH 8MM STOP/44.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10127499 ↗
• MalfunctionAug 31, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN SURGERY, THE DRILL BIT WITH STOP WAS DAMAGED. THE DRILL BROKE DUE TO MISUSE BY THE SURGEON. THE MATERIAL STAYED IN THE HOSPITAL BUT WAS FLAGGED. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS FOR A 1.5MM DRILL BIT/MINI QC WITH 8MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838484 ↗

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