NA 03.118.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982073686), received between Sep 12, 2018 and Feb 12, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER THE CASE, THE HANDLE WOULD NOT ACCEPT THE DRIVER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323002 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THE DEVICE WAS BROKEN BEFORE THE START OF THE PROCEDURE. THE SILVER CAP ON THE BACK OF THE SCREWDRIVER HANDLE WAS NO LONGER ATTACHED, AND THE DEVICE WAS FOUND SEPARATED INTO TWO OR MORE PIECES. THE ISSUE WAS IDENTIFIED PRIOR TO THE OPERATION, AND THE PRODUCT WAS REMOVED FROM THE STERILE FIELD. THERE WAS NO IMPACT ON THE PATIENT OR THE OUTCOME OF THE PROCEDURE, AND NO HARM OR SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895659 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT INTRAOPERATIVE:, THE SURGEON COMPLAINED THAT THE DEVICE WAS BROKEN. THE LATCHING MECHANISM CAME OFF AND THEY WERE UNABLE TO USE THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363612 ↗
• MalfunctionSep 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE TOP OF THE HANDLE WOULD NOT STAY ON. THIS WAS DETERMINED AFTER PUTTING THE SET TOGETHER AFTER THE DECONTAMINATION PROCESS WAS COMPLETE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143945 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DRILL BIT 2.5 L110 BROKE. ADDITIONALLY THE TIP OF SCREWDRIVER STARDRIVE DOES NOT GRIP THE SCREW MAKING IT DIFFICULT TO INSERT IT AND THE SCREWDRIVER HANDLE DOES NOT ALLOW THE SCREW TO BE SCREWED IN PROPERLY. WHEN THE 2.5 DRILL BIT BREAKS, IT IS SOLVED BY USING THE BASIC 3.5 INSTRUMENT FROM THE STOCK, BUT THIS ALSO BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386929 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE HANDLE WAS BROKEN. THERE WAS NO IMPACT TO OR DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256696 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE ITEM WAS BROKEN. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258353 ↗
• MalfunctionDec 1, 2023Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING SURGERY, THE SPECIALIST DRILLS TO PASS A CORTICAL SCREW BUT REFERS THAT THE HANDLE HAS NO FORCE AND IT IS LOOSE APPARENTLY, AND THE TIP DOES NOT HOLD THE SCREWS CAUSING DIFFICULTY INSERTING THEM INTO THE PLATE AND ALSO CAUSES DISCOMFORT IN THE SPECIALIST, IT WAS DELAYED APPROXIMATELY 5 MINUTES OF THE PROCEDURE, THE SURGERY WAS SUCCESSFUL. IT WAS PARTIALLY RESOLVED USING THE HANDLE OF REF 01.118.226 CORRESPONDING TO THE INSTRUMENTAL OF 2.7. THERE WAS NO WAY TO RESOLVE THE ISSUE WITH THE TIP. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) SILIC HAND W/AO/ASIF-QC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250834 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY THE END OF THE QUICK CONNECT HANDLE WAS MISSING AND BROKEN OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728870 ↗
• MalfunctionJun 7, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A CALCANEAL FRACTURE WITH THE VA CALCANEAL 2.7 INSTRUMENT SET. HOWEVER, THE SPRING FOR THE SILICONE HANDLE QUICK COUPLING WAS NOT INCLUDED IN THE SET, AND IT COULDN¿T BE FOUND IN THE OPERATION ROOM. THEREFORE, IT WAS NOT POSSIBLE TO ATTACH A DRIVER SHAFT TO THE HANDLE FOR TORQUE LIMITERS. THE SURGERY WAS COMPLETED SUCCESSFULLY USING OTHER HANDLES. THERE WAS NO DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080763 ↗
• MalfunctionMar 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT FOR THE FOLLOWING PRODUCTS: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SILICONE HNDL/QC ROTATING CAP WAS BROKEN FROM THE CAP OF THE TIP. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EXAMINATION. NO OTHER ISSUES WERE FOUND. NO ADDITIONAL INFORMATION IS KNOWN. HOWEVER, IT COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) SILICONE HNDL/QC ROTATING CAP THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482385 ↗
• MalfunctionFeb 23, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, PRE-OPERATIVELY DURING THE INSPECTION THE SCREWDRIVER HANDLE WAS BROKEN INTO MULTIPLE PIECES AT THE ATTACHMENT POINT. THIS DEVICE SHOULD BE REPLACED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431133 ↗
• MalfunctionFeb 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED ON AN UNKNOWN DATE, THE SCREWDRIVER SWIVEL END BROKE OFF AND THE TIP OF THE SCREWDRIVER ALSO FELL APART. THERE WAS NO PATIENT OUTCOMES REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SILICONE HNDL/QC ROTATING CAP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387223 ↗
• MalfunctionJan 23, 2023Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE UNABLE TO BE STERILIZED/ASSEMBLED, CHIPPING AND CRACKING WAS REPORTED AND WERE UNABLE TO BE USED. THIS REPORT IS FOR ONE (1)SILICONE HNDL/QC ROTATING CAP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225606 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE ROTATING CAP ON HANDLE WAS BROKEN OFF. PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE (1) SILICONE HNDL/QC ROTATING CAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193662 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2022, THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754544 ↗
• MalfunctionMar 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, AT FSL (B)(4) . IT WAS OBSERVED THAT 03.118.111, SILICONE HNDL/QC ROTATING CAP, LOT UNKNOWN WAS BROKEN.. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE SILICONE HNDL/QC ROTATING CAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840217 ↗
• MalfunctionAug 6, 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, THE SILICONE HANDLE/QUICK COUPLING WAS FOUND TO NOT BE WORKING CORRECTLY. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE WAS DISCOVERED DURING SERVICING. THIS REPORT IS FOR (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288757 ↗
• MalfunctionApr 2, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A FOOT SURGERY, THE SILICONE HANDLE/QUICK COUPLING HANDLE WAS BROKEN. THE SCREWDRIVER SHAFT WAS UNABLE TO BE FIXED INTO THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER SHAFT (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609200 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SILICONE HANDLE/QUICK COUPLING WITH ROTATING CAP HAD A BROKEN HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474267 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING DISTAL FIBULA SURGERY USING VARIABLE ANGEL (VA) ANKLE SYSTEM, ONE (1) 2.0MM DRILL BIT BROKE AND ONE (1) SCREWDRIVER HANDLE WAS DAMAGED. THE DRILL BIT 2.0MM BROKE DURING DRILLING OF PROXIMAL SCREW AND THE BROKEN DRILL SHAFT WAS RETAINED IN DRILL. THE BROKEN DRILL TIP FELL ONTO THE FLOOR, A NEW DRILL BIT WAS SELECTED AND THE PROCEDURE CONTINUED WITHOUT INCIDENT. THE SCREWDRIVER HANDLE'S ROTATING CAP BROKE OFF DURING USE. THE SURGEON CONTINUED USE OF SCREWDRIVER WITHOUT INCIDENT. THERE WERE TWO (2) MINUTES OF SURGICAL DELAY. FRAGMENTS WERE EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME AS PLANNED. CONCOMITANT DEVICE REPORTED: UNK - DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11224460 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT DURING HARDWARE REMOVAL IN THE ANKLE DUE TO INFECTION ON (B)(6) 2020, THE END PART OF THE SILICONE HANDLE WITH ROTATING CAP WAS BROKEN AND SPINNING. THE ISSUE HAPPENED WHEN THE SURGEON HIT THE REPORTED DEVICE WITH A HAMMER AND SCREWDRIVER. THEY LOSS THE BROKEN PART BUT THEY JUST FOUND IT AND JUST COLLECTED IT. A TORQUE LIMITING SCREWDRIVER HANDLE WAS USED TO CONTINUE WITH THE CASE. THE ISSUE DID NOT SLOW THE SURGERY DOWN. THE PROCEDURE WAS COMPLETED AND THERE WAS NO IMPACT ON THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREWDRIVER (PART # UNKNOWN LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10958982 ↗
• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SILICON HANDLE/QUICK COUPLING WITH ROTATING CAP CIRCULAR PIECE ON BOTTOM WAS DISCONNECTED FROM THE HANDLE. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10517825 ↗
• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THE CIRCULAR PIECE ON BOTTOM OF A SILICONE HANDLE WITH QUICK COUPLING WAS DISCONNECTED. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10517742 ↗
• MalfunctionSep 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SILICONE HANDLE/QUICK COUPLING W/ROTATING CAP TOP WILL NOT STAY ATTACHED AND THE STARDRIVE SCREWDRIVER SHAFT THREADS ARE DESTROYED ON THE DRIVER. THE MALFUNCTIONS OCCURRED INTRAOPERATIVELY DURING AN UNKNOWN PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476034 ↗