NA 312.648Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10886982187840), received between Jun 7, 2017 and Sep 9, 2024 — classified as 57 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (42 reports).

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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE DEVICES BECAME STUCK TOGETHER WHEN INSERTING THE DRILL GUIDE. DEVICES WOULD NOT COME APART. STAFF USED THE OTHER DRIVER AND DRILL GUIDES TO COMPLETE THE CASE. NO DELAY IN CASE AND NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. PROCEDURE COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE 2.8MM THREADED DRILL GUIDE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168325 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212299 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212298 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212295 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212292 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212290 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE . THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212289 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212288 ↗
• MalfunctionNov 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS ON THE DRILL SLEEVES ARE WORN OUT. THEY DO NOT ENGAGE IN THREADED HOLES PROPERLY ANYMORE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212283 ↗
• MalfunctionOct 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  EVENT IS A VETERINARY COMPLAINT FOR A DOG. NO HUMAN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17988173 ↗
• MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2023, THE SURGEON COMPLAINED THAT SOME OF THE OLDER SMALL FRAGMENT LOCKING TOWERS DID NOT WANT TO SCREW INTO A PLATE. NO ADVERSE EVENTS OCCURRED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOMES. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17091886 ↗
• MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2023, THE SURGEON COMPLAINED THAT SOME OF THE OLDER SMALL FRAGMENT LOCKING TOWERS DID NOT WANT TO SCREW INTO A PLATE. NO ADVERSE EVENTS OCCURRED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOMES. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17091567 ↗
• MalfunctionMar 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, ONE OF THE HOLES IN THE PLATE WOULD NOT ALLOW THE LOCKING TOWER TO SCREW INTO THE PLATE. THE PLATE HOLE WAS LIKELY SLIGHTLY STRIPPED OUT OR SOFT TISSUE WAS BLOCKING THE TOWER FROM SCREWING IN. THE SURGEON FREE HAND DRILLED FROM THE SCREW AND THE SCREW SUCCESSFULLY LOCKED INTO THE PLATE. NO ADVERSE EVENTS OCCURRED IN SURGERY. THERE WERE NO COMPLAINTS AGAINST THE TOWERS AS THEY WORKED IN THE OTHER HOLES. SURGICAL DELAY OF 5 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632114 ↗
• MalfunctionJan 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON JANUARY 3, 2023, IT WAS NOTICED THAT DRIVE SHAFTS WERE WARPED AND THE THREAD GUIDE IN THREADS WERE WARPED WHEN PUTTING THE SETS TOGETHER IN SPD. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245908 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739845 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739843 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739842 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739790 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739788 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739748 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739743 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) 2.8MM THREADED DRILL GUIDES WERE HAVING ISSUES THREADING INTO LOCKING PLATES AND T15 STAR SCREWDRIVERS. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739658 ↗
• MalfunctionOct 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SURGEON ATTEMPTED TO PUT A GUIDE BLOCK AND SCREW THROUGH THE DRILL HOLES. THE ISSUE OCCURRED WHILE THE ATTACHMENT SCREW GOING TO THE PATIENT'S BODY VIA THE GUIDE BLOCK. WE ARE DOING A DISTAL FIBULA PLATE FOR A PATIENT AND DRILLED FOR A LOCKING SCREW THEN USE THE POWER SHAFT. THE LOCKING SCREW WOULD NOT STICK TO THE TIP OF THE SCREWDRIVER SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE HAND SCREWDRIVER AND A SURGICAL DELAY OF THIRTY(30) SECONDS. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: DISTAL RADIUS: (PART#UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665180 ↗
• MalfunctionJul 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF BACK UP IT WAS NOTED THAT THE TWO (2) THREADED DRILL SLEEVE ARE PRESSED, SO THEY ARE FLAT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10237308 ↗
• MalfunctionJul 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF BACK UP IT WAS NOTED THAT THE TWO (2) THREADED DRILL SLEEVE ARE PRESSED, SO THEY ARE FLAT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10237307 ↗