NA 314.15Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982188595), received between Mar 4, 2019 and Sep 15, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Crack; Material Twisted/Bent; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780286 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LARGE HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18122279 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LARGE HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121727 ↗
• MalfunctionJun 9, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM BERMUDA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE HEXAGONAL SCREW DRIVER SHAFT BROKE INTO TWO PIECES. NO PATIENT CONSEQUENCES OR PROLONGED HOSPITALIZATION WERE REPORTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER A 10 MINUTE DELAY. THIS REPORT IS FOR A LARGE HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643214 ↗
• MalfunctionMay 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) REDUCTION FORCEP POINTS RACHET, PROTECTION SLEEVE, TROCAR, SHARP HOOK, INSERTION GUIDE, TWO (2) T-HANDLE WITH QUICK COUPLING, SCREWDRIVER SHAFT, DRIVING CAP AND RADIOLUCENT INSERTION HANDLE WERE FOUND DAMAGED AFTER USE IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) LARGE HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345741 ↗
• MalfunctionMar 17, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING SHOULDER REPAIR SURGERY TIPS OF SMALL HEXAGONAL SCREWDRIVER SHAFT AND LARGE HEXAGONAL SCREWDRIVER SHAFT WERE STRIPPED OFF. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792414 ↗
• MalfunctionJan 31, 2022Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON (B)(6), 2021, THE LARGE HEXAGONAL SCREWDRIVER SHAFT HAVE A SMALL NICK IN THE AO CONNECTOR PORTION AND THE SCRUB TECH WAS HAVING A DIFFICULT TIME GETTING THE POWER HEX DRIVE TO SEAT PROPERLY INTO THE QUICK CONNECT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER SHAFT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392169 ↗
• MalfunctionApr 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT WHO HAD A GENETIC DISORDER WITH REALLY HARD BONE UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT HIP USING A PROXIMAL FEMUR LOCKING PLATE ON A SUBTROCH HIP FRACTURE. DURING THE PROCEDURE, WHILE PUTTING IN SCREWS, A CANNULATED HEXAGONAL SCREWDRIVER AND A HEXAGONAL SCREWDRIVER SHAFT GOT STRIPPED. A BACKUP SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996496 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION, AT THE FIELD STOCKING LOCATION, IT WAS OBSERVED THAT THE LARGE HEXAGONAL SCREWDRIVER SHAFT WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED FROM THE FIELD. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8388519 ↗