NA 314.29Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886982188762), received between Nov 8, 2017 and Apr 8, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER IS LOOSE AND TWIT WHEN SCREWING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820100 ↗
• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224018 ↗
• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223528 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT A HANDLE OF THE CANNULATED 2.5MM HEXAGONAL SCREWDRIVER IS BROKEN. THERE WAS NO PROCEDURE AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212033 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE 5 ITEMS THAT WERE BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED: DEPTH GAUGE FOR LCKNG SCRS TO 100: TIP OF DEPTH GAUGE HAS BEEN BENT BEYOND THE ABILITY TO BE USED. DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS: METAL TIP BROKE OFF THE DEPTH GAUGE. T-HANDLE WITH QUICK COUPLING: T HANDLE BROKE WHERE THE T CONNECTS TO THE SHAFT. NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW (X2): SPRING FOR THE INSTRUMENT TO LONG INTO THE AIMING ARM BROKE. TROCAR HANDLE FOR USE 03.120.014: SPRING ON THE INSTRUMENT HAS BEEN USED SO OFTEN A TROCAR WILL NO LONGER LOCK ON. CANNULATED 2.5MM HEXAGONAL SCREWDRIVER: WOOD IS CRACKED ON THE HANDLE. GUIDE BLOCK FOR 2 COLM PL 6 HOLE HD/LFT: THE SCREW TO CONNECT THE GUIDE BLOCK IS BROKEN. ISSUES WERE NOTED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456387 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT HANDLE SPLIT AND NEEDS TO BE REPLACED FOR SPD TO STERILIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105893 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT HANDLE SPLIT AND NEEDS TO BE REPLACED FOR SPD TO STERILIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105879 ↗
• MalfunctionDec 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLES LEAVE A STAIN ON PEEL PACKS AFTER STERILIZATION PROCESSING. NO PATIENT WAS INVOLVED. THIS EVENT OCCUR DURING FIELD INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918096 ↗
• MalfunctionSep 10, 2024Break; Device Slipped; Break; Device Slipped

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE DEVICE HAD ISSUES WITH THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185850 ↗
• MalfunctionAug 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE END OF THE HEX IS ROUNDED OFF. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT INVOLVES ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047758 ↗
• MalfunctionAug 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING FIELD INSPECTION/PROCESSING, IT WAS DISCOVERED THAT THE SCREWDRIVER HANDLES ARE LEAVING A STAIN ON THE PEEL PACKS. THERE WERE NO PATIENT INVOLVEMENT, THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968058 ↗
• MalfunctionMar 10, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A PROBLEM WITH THE CELERON CABLES. AFTER THE STERILIZATION PROCESS, THE REMOVAL KEYS SHOWED RESIDUE ON THE WOODEN HANDLES, COMPROMISING THE STERILITY AND USE OF THE MATERIAL. THIS WAS DISCOVERED PREOPERATIVELY DURING THE STERILIZATION PROCESS. THIS REPORT INVOLVES ONE CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520627 ↗
• MalfunctionJan 25, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE PATIENT OUTCOME WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244482 ↗
• MalfunctionNov 28, 2022Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE SCREWDRIVER SLEEVE HAS BECOME LOOSE AND IS NOT HOLDING RELIABLY. EITHER THE SHAFT OR SLEEVE OR BOTH HAVE WORN OUT. NO CASE OR PATIENT IMPACTED PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15872682 ↗
• MalfunctionJun 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE AT AN UNKNOWN DATE IN 2022, WHILE TIGHTENING A 4.0MM CANNULATED SCREW, THE HAND SCREWDRIVER STRIPPED AND STOPPED FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY ATTACHING THE HAND DRIVER TO A POWER SCREWDRIVER. THIS REPORT IS FOR A CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658194 ↗
• MalfunctionJan 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021. DURING AN UNKNOWN PROCEDURE, THE CANNULATED 2.5MM HEXAGONAL SCREWDRIVER WAS USED BY THE SURGEON WHEN PUTTING A SCREW INTO THE PATIENT'S BODY WHEN THE SCREWDRIVER WITH SHAFT ACCIDENTALLY SLIPPED FORWARD SO IT WAS CONSIDERED CONTAMINATED. SURGEON USED A CANNULATED POWER SHAFT THAT WAS IN THE SET AND ATTACHED THE SCREWDRIVER HANDLE TO COMPLETE THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206213 ↗
• MalfunctionMay 3, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.7MM VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK INTO THE FOURTH MOST PROXIMAL HOLE OF THE 2.7MM/3.5MM VARIABLE ANGLE LCP POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT. BOTH IMPLANTS REMAINED IN THE PATIENT. THE 4.0MM CANNULATED SCREW SHORT AND 4.0MM CANNULATED SCREW SHORT THREAD 64MM WERE STRIPPED OR THE CANNULATED HEX SCREWDRIVER WAS STRIPPED. A SECOND SET FOR ANOTHER SCREWDRIVER WAS OPENED AND THE HANDLE BROKE. BOTH SCREWS REMAINED IN THE PATIENT. THERE WAS TEN (10) MINUTES OF SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760550 ↗
• MalfunctionMay 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.7MM VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK INTO THE FOURTH MOST PROXIMAL HOLE OF THE 2.7MM/3.5MM VARIABLE ANGLE LCP POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT. BOTH IMPLANTS REMAINED IN THE PATIENT. THE 4.0MM CANNULATED SCREW SHORT AND 4.0MM CANNULATED SCREW SHORT THREAD 64MM WERE STRIPPED OR THE CANNULATED HEX SCREWDRIVER WAS STRIPPED. A SECOND SET FOR ANOTHER SCREWDRIVER WAS OPENED AND THE HANDLE BROKE. BOTH SCREWS REMAINED IN THE PATIENT. THERE WAS TEN (10) MINUTES OF SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760458 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE CANNULATED 2.5MM HEXAGONAL SCREWDRIVER HANDLE BROKE. THE SURGERY WAS DELAYED FOR 3 MINUTES. USED DIFFERENT DRIVER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641263 ↗
• MalfunctionFeb 19, 2021Break; Break

  IT WAS REPORTED THAT THE 314.29 HANDLE BROKE DURING SURGERY. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED AND THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. THIS COMPLAINT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348089 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT THE CANNULATED 2.5MM HEXAGONAL SCREWDRIVER WAS FOUND BROKEN WHILE PUTTING THE SET BACK TOGETHER POST-SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322508 ↗
• MalfunctionMar 23, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE CANNULATED HEXAGONAL SCREWDRIVER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865578 ↗
• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED THAT DURING STERILE PROCESSING ON (B)(6) 2019, THE HANDLE OF A CANNULATED HEXAGONAL SCREWDRIVER WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9177123 ↗
• MalfunctionSep 10, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE PICKING UP THE SET, THE SALES CONSULTANT NOTICED THAT A CANNULATED HEXAGONAL SCREWDRIVER WAS NOTED TO HAVE A SLIGHTLY TWISTED ON THE END MAKING IT DIFFICULT TO SEAT INTO AN UNKNOWN SCREW HEADS. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED 2.5 MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8982645 ↗
• MalfunctionAug 8, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A HARDWARE REMOVAL OF CANNULATED SCREWS, THE CANNULATED HEXAGONAL SCREWDRIVER HANDLE BROKE. FRAGMENTS WERE GENERATED BUT REMOVED EASILY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: CANNULATED HEXAGONAL SCREWDRIVER SHAFT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), CANNULATED SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT CAPTURES THE BROKEN SCREWDRIVER. THE NEED FOR THE REVISION PROCEDURE IS CAPTURED ON RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A CANNULATED HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874413 ↗