NA 03.133.150Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886982270351), received between Jun 21, 2021 and Apr 23, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT TWO (2) SCREWDRIVER HANDLE UNIV WERE DAMAGED AFTER USE IN THE OPERATING ROOM. THE SILICONE ON THE HANDLES IS DAMAGED (MATERIAL MISSING/SILICONE TORN AWAY) AND CANNOT BE RETURNED TO CIRCULATION. THERE WAS A RISK OF PARTICLE EMISSION, WHICH COULD POTENTIALLY LEAD TO INFECTION. THE CONSEQUENCE OF THE EVENT WAS MISSING HANDLES IN THE ANCILLARY SET, CAUSING PROBLEMS FOR SCREWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971751 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT TWO (2) SCREWDRIVER HANDLE UNIV WERE DAMAGED AFTER USE IN THE OPERATING ROOM. THE SILICONE ON THE HANDLES IS DAMAGED (MATERIAL MISSING/SILICONE TORN AWAY) AND CANNOT BE RETURNED TO CIRCULATION. THERE WAS A RISK OF PARTICLE EMISSION, WHICH COULD POTENTIALLY LEAD TO INFECTION. THE CONSEQUENCE OF THE EVENT WAS MISSING HANDLES IN THE ANCILLARY SET, CAUSING PROBLEMS FOR SCREWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971748 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT TWO (2) UNIVERSAL SCREWDRIVER HANDLES WERE BROKEN. QUICK CONNECT CHUCK DOES NOT LOCK SCREWDRIVER SHAFT IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183403 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT TWO (2) UNIVERSAL SCREWDRIVER HANDLES WERE BROKEN. QUICK CONNECT CHUCK DOES NOT LOCK SCREWDRIVER SHAFT IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183402 ↗
• MalfunctionDec 10, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE HOLDING MECHANISM BECAME DISASSEMBLED. ATTEMPTS WERE MADE TO PUT IT BACK TOGETHER, BUT IT APPEARS TO BE MISSING A PIN. IT IS UNKNOWN HOW IT CAME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768905 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT THE UNIVERSAL SCREWDRIVER HANDLE IS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598567 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT THE PERIOSTEAL ELEVATOR 6MM CURVED BLADE DRIVER COLLET SNAPPED, RESULTING IN LOOSE CONNECTION (X2), WILL NO LONGER HOLD DRIVERS. THE UNIVERSAL SCREWDRIVER HANDLE TIPS (X2) HAVE CHIPPED AND SHARPENED. THESE ARE UNABLE TO BE USED. THE SCREW DRIVER/CANNULATED/XL25 DRIVER AND RETENTION PIN BECAME BOUND, AND PIN IS UNABLE TO BE REMOVED. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057580 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT THE PERIOSTEAL ELEVATOR 6MM CURVED BLADE DRIVER COLLET SNAPPED, RESULTING IN LOOSE CONNECTION (X2), WILL NO LONGER HOLD DRIVERS. THE UNIVERSAL SCREWDRIVER HANDLE TIPS (X2) HAVE CHIPPED AND SHARPENED. THESE ARE UNABLE TO BE USED. THE SCREW DRIVER/CANNULATED/XL25 DRIVER AND RETENTION PIN BECAME BOUND, AND PIN IS UNABLE TO BE REMOVED. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057578 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNIVERSAL SCREWDRIVER HANDLE. THIS IS REPORT 2 OF 8 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19694358 ↗
• MalfunctionApr 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MAR 18, 2024 THE SCREWDRIVER HANDLES WON'T ATTACH PROPERLY. THERE WAS NO OPERATION AND PATIENT INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) UNIVERSAL SCREWDRIVER HANDLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031520 ↗
• MalfunctionApr 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREWDRIVER HANDLES WON'T ATTACH PROPERLY. THERE WAS NO OPERATION AND PATIENT INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) UNIVERSAL SCREWDRIVER HANDLE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031496 ↗
• MalfunctionDec 11, 2023Break; Device Slipped; Break; Device Slipped

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT AN UNKNOWN SURGERY. PRIOR TO THE PROCEDURE, WHEN STERILIZATION WAS ATTEMPTED THE HANDLE TIP WAS TAKEN OFF. WHEN THE HANDLE WAS ASSEMBLED, IT WAS FOUND TO BE LOOSENING. IT WAS NOT USED DURING THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A UNIVERSAL SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300568 ↗
• MalfunctionOct 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THERE WAS BREAKAGE OF THE UNIVERSAL SCREWDRIVER HANDLE. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE UNIV. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887136 ↗
• MalfunctionAug 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AUG 3, 2023, THE CONNECTOR WAS NO LONGER HOLDING THE DRIVER SHAFTS. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIVERSAL SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568593 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE DRILLS DID NOT FIT THE INSTRUMENT. THE INSTRUMENT WAS NEW. THERE WAS NO DELAY IN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) UNIVERSAL SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413023 ↗
• MalfunctionJun 8, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, WHEN THE UNIVERSAL SCREWDRIVER HANDLE WAS CHECKED BEFORE THE FIRST USE, IT WAS FOUND THAT THE TIP PART OF THE QUICK COUPLING CAME OFF. SINCE THIS WAS NOT NORMAL, IT WAS REPLACED WITH A NEW PRODUCT. THIS REPORT INVOLVES ONE UNIVERSAL SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085818 ↗
• MalfunctionMay 3, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT A REMOVAL SURGERY. DURING SURGERY, THE COUPLING PART OF THE HANDLE BROKE AND THE SPRING AT THE TIP OF THE HANDLE CAME OFF WHEN A SCREWDRIVER TIP WAS INSERTED INTO THE HANDLE. REMOVAL OF IMPLANTS WAS DONE BY ANOTHER SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30 MINUTES DELAY. AFTER SURGERY, THE DISENGAGED SPRING WAS LOST DURING WASHING. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE UNIV. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863562 ↗
• MalfunctionDec 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SLOT IN CASE NUMBER (B)(4) IS TOO SLIM TO FIT THE INSTRUMENT, THIS COULD BE THE REASON THAT A CRACK IS PRODUCED IN THE HANDLE WHEN TRY TO PUT THE INSTRUMENT INTO THE CASE TIGHTLY. THIS WAS DETECTED DURING INSPECTION FOR LOANER SETS. NO PATIENT INVOLVED. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE UNIV THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904262 ↗
• MalfunctionNov 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR THE DIAPHYSEAL FRACTURE OF THE ANTEBRACHIAL BONE. DURING THE SURGERY, WHEN THE SURGEON PREPARED THE SCREWDRIVER HANDLE IN QUESTION FOR SURGERY, THE SLIVER CONNECTION PART OF THE HANDLE WAS OFF. ALTHOUGH THE NURSE TRIED TO ATTACH THE SLIVER CONNECTION PART TO THE HANDLE, IT WAS ONLY LIGHTLY ATTACHED. A SCREWDRIVER SHAFT COULD NOT BE ATTACHED TO THE HANDLE. THE HANDLE IN QUESTION WAS REQUIRED BECAUSE THE SURGEON DROPPED A HANDLE DURING THE SURGERY. HOWEVER, THE HANDLE IN QUESTION COULD NOT BE USED. THEREFORE, ANOTHER HANDLE WAS USED INSTEAD OF THE HANDLE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. AFTER THE SURGERY, ALTHOUGH THE SALES REP TRIED TO ATTACH THE SLIVER CONNECTION PART TO THE HANDLE, IT COULD NOT BE ATTACHED FIRMLY. THE AGENT DID NOT FIND ANY MALFUNCTION AT THE TIME OF DELIVERY. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS: SHAFTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE UNIV. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796913 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF PROXIMAL END OF TIBIA. FOR TIBIAL PLATEAU FRACTURE, THE SURGEON TRIED TO FIX WITH A MEDIAL PROXIMAL TIBIA PLATE FROM POSTERIOR SIDE. BECAUSE THE OPERATIVE FIELD WAS DEEP AND NARROW, THE SALES REP INSTRUCTED THE SURGEON TO PERFORM THE PROCEDURES ACCORDING TO THE USF SURGICAL TECHNIQUE AND CATALOG. SURGERY WAS PERFORMED ACCORDING TO THAT SURGICAL TECHNIQUE AND COMPLETED WITHIN 30 MINUTES DELAY. BASED ON THE EVENT "ANOTHER SURGEON NOTICED THIS, REATTACHED THE THREADED GUIDE PROPERLY AGAIN, AND FIXED THE PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE UNIV. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037625 ↗