NA 314.55Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982188953), received between Mar 13, 2017 and Aug 13, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234324 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234235 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234222 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234186 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234176 ↗
• MalfunctionMay 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE ENDS OF THE SCREWDRIVER TIPS WERE ROUNDED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174510 ↗
• MalfunctionMay 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE ENDS OF THE SCREWDRIVER TIPS WERE ROUNDED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174283 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT SCREW DRIVER BROKE DURING SCREW IMPLANTATION. DEPTH GAUGE IS STICKY AND IS VERY DIFFICULT TO USE. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587271 ↗
• MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PELVIC HEX SCREWDRIVERS WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318438 ↗
• MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PELVIC HEX SCREWDRIVERS WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318432 ↗
• MalfunctionMay 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWDRIVERS WERE STRIPPED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) SDDRIVE SCREWDRIVER SHAFT QC/T15. THIS IS REPORT 4 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923832 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286151 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286144 ↗
• MalfunctionFeb 1, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, HEAD OF SCREWDRIVER SNAPPED OFF WHILE FINAL TIGHTENING OF SCREW AND WAS RETAINED IN SCREW HEAD. RETAINED BROKEN SCREWDRIVER PART WAS REMOVED FROM PATIENT ALONG WITH THE SCREW IN WHICH IT BROKE INTO. THERE WAS APPROXIMATELY 30 MINUTES DELAY TO RETRIEVE BROKEN HARDWARE. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT/LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280627 ↗
• MalfunctionAug 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE TIP OF THE SCREWDRIVER IN QUESTION BROKE OFF IN THE SCREW AND COLD WELDED INTO THE SCREW HEAD RECESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER SHAFT/LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283073 ↗
• MalfunctionJun 28, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SHAFT TIP TWISTED AND TORQUED, AND IS UNABLE TO BE USED. THE HOSPITAL PROVIDED THE INSTRUMENTATION TO THE SALES REP WITHOUT ANY EXPLANATION ON EVENT OR CASE INFORMATION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER SHAFT/LONG. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842085 ↗
• MalfunctionFeb 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, ALL SCREWDRIVER APPEARS TO BE STRIPPED AND WILL BE UNABLE TO RETAIN AND OR TURN THE SCREWS. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) SMALL HEXAGONAL SCREWDRIVER SHAFT/LONG. THIS IS REPORT 1 OF 5 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314562 ↗
• MalfunctionFeb 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, ALL SCREWDRIVER APPEARS TO BE STRIPPED AND WILL BE UNABLE TO RETAIN AND OR TURN THE SCREWS. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) SMALL HEXAGONAL SCREWDRIVER SHAFT/LONG. THIS IS REPORT 3 OF 5 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314560 ↗
• InjuryOct 10, 2019Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA ON (B)(6) 2019, WHILE THE SURGEON WAS ON THE FINAL TIGHTENING OF AN UNKNOWN CORTEX SCREW, THE TIP OF THE SMALL HEXAGONAL SCREWDRIVER SHAFT BROKE OFF IN THE HEAD OF THE SCREW. THE BROKEN PIECE WAS NOT RETRIEVED. THERE WAS A MINIMAL SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED USING A SIMILAR SCREWDRIVER FOR THE REMAINING SCREWS. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9176753 ↗
• MalfunctionJun 13, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA PROCEDURE, A SCREW DRIVER HEAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED DELAY. THERE ARE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER SHAFT/LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7597305 ↗
• InjuryMar 13, 2017Break; Break

  IT WAS REPORTED THAT DURING A TIBIA PLATEAU PROCEDURE ON (B)(6) 2017, THE TIP OF A SMALL HEXAGONAL SCREWDRIVER BROKE IN HALF WHILE INSERTING A 3.5 MM CORTEX SCREW. IT WAS A CLEAN BREAK. THE TIP WAS NOT RETRIEVED AND LEFT IN THE PATIENT. THE SCREW WAS IMPLANTED USING A BACKUP SCREWDRIVER. NO MEDICAL INTERVENTION REQUIRED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: 3.5 MM CORTEX SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY 1). THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6399128 ↗