NA 314.114Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982188526), received between Nov 7, 2017 and Feb 12, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, A SCREWDRIVER WAS FOUND IN SPD WITH A TWISTED/DEFORMED TIP. THE SCREWDRIVER WAS NO LONGER USABLE. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 21364543 ↗
• MalfunctionJul 22, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE THAT DURING THE ROUTINE INSPECTION THE CANNULATED SDDRIVE SCREWDRIVER/T15 WERE FOUND TO BE DAMAGED. NO PATIENT IS INVOLVED. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) CANNULATED SDDRIVE SCREWDRIVER/T15 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089102 ↗
• MalfunctionApr 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS FOUND OUT THAT THE TIPS OF THE TWO CANNULATED STARDRIVE SCREWDRIVER T15 SCREWDRIVERS WERE BENT. NO PATIENT CONSEQUENCE. PATIENT OUTCOME WAS GOOD. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DISTAL TIP (DRIVE FEATURE) OF THE DEVICE WAS TWISTED, NOT BENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688584 ↗
• MalfunctionSep 4, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION OF SETS, ONE (1) BOLT CUTTER CUTTING EDGE WAS CHIPPED, TWO (2) DEPTH GAUGE OUTER SLEEVE FALLS OFF DUE TO MISSING BEARING, ONE (1) DEPTH GAUGE HAS A BROKEN TIP, ONE (1) GUIDE SLEEVE HAS A BROKEN/ BENT TIP, ONE (1) CANNULATED STARDRIVE TWISTED TIP, TWO (2) SCREWDRIVERS HAS A BROKEN TIP. ONE (1) DRIVING CAP HAS A BROKEN TIP, ONE (1) EXTRACTION INSTRUMENT WAS STRIPPED INSERTION THREADS, ONE (1) HANDLE WITH QUICK COUPLING HAS A BROKEN HANDLE, ONE (1) HANDLE SLEEVE WITH UNKNOWN ALLEGATION: ONE (1) TORQUE LIMITER AND ONE (1) TENSION HOLDER DRIVER WON'T LOCK, AND ONE (1) DRILL SLEEVE HAS AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIFTEEN (15) DEVICES. THIS REPORT IS FOR (1) CANNULATED STARDRIVE SCREWDRIVER/ T15. THIS IS REPORT 4 OF 8 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497230 ↗
• MalfunctionDec 26, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2018, THE T15 CANNULATED SCREWDRIVER THAT IS ON CANNULATED SCREW SET WAS FOUND DAMAGED. IT IS UNKNOWN WHEN THE ISSUE HAPPENED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. DURING INVESTIGATION OF THE RETURNED DEVICE IT WAS NOTED THE DISTAL CANNULATED T15 TIP IS SIGNIFICANTLY TWISTED (POST MANUFACTURING DAMAGE) IN THE DIRECTION OF RESISTANCE ENCOUNTERED DURING SCREW INSERTION. THIS REPORT IS FOR A CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197145 ↗
• MalfunctionNov 14, 2017Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE TIPS ARE STRIPPED ON ONE CANNULATED SCREWDRIVER AND ONE CANNULATED SCREWDRIVER SHAFT. THIS WAS DISCOVERED DURING ROUTINE INSPECTION OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICES HAVE BEEN USED BEFORE AND ARE APPROXIMATELY 6 YEARS OLD. THERE WAS NO UNUSUAL USE OF DEVICES AND THEY HAD BEEN USED AS INTENDED. THERE WAS NO DAMAGE NOTED ON THE MATING INSTRUMENTS PRIOR TO THIS COMPLAINT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7029043 ↗
• MalfunctionNov 7, 2017Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL HUMERUS THAT A CANNULATED STARDRIVE SCREWDRIVER WAS WORN SO IT WOULD NOT SEAT WITH THE SCREW. ANOTHER SCREWDRIVER WAS READILY AVAILABLE AND THE SURGERY CONTINUED WITH NO DELAY, NO MEDICAL INTERVENTION AND WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE FOLLOWING THE SURGERY. CONCOMITANT MEDICAL DEVICE: UNKNOWN SCREW (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7007006 ↗