NA 310.510Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10887587035154), received between Jan 16, 2018 and May 27, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED DURING THE PROCEDURE IT IS OBSERVED THAT THE K NEEDLES ARE IN POOR CONDITION, SCRATCHED IN THEIR DISTAL MIDDLE THIRD THESE IF USED IN THE PATIENT. IN ADDITION, ROCK OF 1.8 IS BROKEN WITHOUT CAUSING DAMAGE TO THE PATIENT. HOWEVER, AS ONLY ONE COMES IN THE EQUIPMENT, IT LIMITS THE PROPER PLACEMENT OF 2.4 CORTICAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090724 ↗
• MalfunctionMay 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE QUICK-ACTION COUPLING OF THE DRILL BIT DOES NOT FIT INTO THE DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026069 ↗
• MalfunctionJan 29, 2024Failure to Cut; Failure to Cut

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AND OUTCOME WERE REPORTED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595190 ↗
• MalfunctionDec 29, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION BROKE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18416694 ↗
• MalfunctionSep 14, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION BROKE WHEN IT WAS REMOVED FROM THE BONE. NO FRAGMENTS WERE LEFT IN THE PATIENT, ALL WERE REMOVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING A REPLACEMENT DRILL BIT. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746451 ↗
• MalfunctionJul 26, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION SPLIT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397160 ↗
• MalfunctionJul 14, 2023Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS IT WAS REPORTED ON JUNE 21, 2023, THAT THE DRILL BIT BENT DURING SURGICAL PROCEDURE, IN ADDITION TO NOT HAVING A PROPER EDGE TO BE ABLE TO PERFORM THE DRILLING IN THE PATIENT. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT/QC/100MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17327482 ↗
• MalfunctionJan 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT SPLIT DURING SURGERY. IT AFFECTED THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 16232006 ↗
• MalfunctionAug 1, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE DRILL BIT IN QUESTION BROKE DURING DRILLING. THERE WAS NO ADVERSE PATIENT OUTCOME. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142167 ↗
• MalfunctionJul 21, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE DRILL BIT BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074312 ↗
• MalfunctionNov 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 THE 1.8MM DRILL BIT WAS BENT AND 2.0MM DRILL BIT WAS DULL. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12812688 ↗
• 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)1.8MM DRILL BIT/QC/100MM. THIS REPORT IS 11 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389104 ↗
• 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) 1.8MM DRILL BIT/QC/100MM. THIS REPORT IS 3 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388753 ↗
• MalfunctionMay 31, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT DIFFERENT DRILL BIT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910660 ↗
• MalfunctionFeb 22, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT 2 (TWO) DRILL BIT ARE WORN INTRA-OPERATIVELY. IT WAS UNKNOWN HOW IT¿S OCCURRED. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.8MM DRILL BIT/QC/100MM THIS IS REPORT 1 OF 2 PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362256 ↗
• MalfunctionFeb 22, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT 2 (TWO) DRILL BIT ARE WORN INTRA-OPERATIVELY. IT WAS UNKNOWN HOW IT¿S OCCURRED. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362253 ↗
• MalfunctionJan 16, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE 1.8MM DRILL BIT WAS IDENTIFIED TO BE DAMAGED BEFORE SURGERY. THE DRILL BIT APPEARED LONGER AT THE TIP. SURGICAL STAFF DID NOT FEEL COMFORTABLE USING THE DEVICE, IT WAS DISCARDED AND NOT USED FOR THE PROCEDURE. THERE IS NO PATIENT INVOLVEMENT OR SURGICAL DELAY REPORTED. INVESTIGATION OF THE RETURNED DEVICE REVEALED IT IS DULL. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7197477 ↗

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