NA 314.67Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10887587037592), received between Dec 21, 2018 and Mar 9, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE 1.5/2.0 SCRDRIVER BLD HOLDING SLV, SHT WAS WORN DOWN AND RENDERED UNUSABLE DUE TO ROUTINE WEAR-AND-TEAR. THERE WAS NO PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY WAS REPORTED. THE DEVICE WAS NOT FOUND TO BE DEFECTIVE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544001 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER HOLDING SLEEVE WAS WORN DOWN AND NOT USABLE DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520691 ↗
• MalfunctionNov 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE DOES NOT CATCH ON THE SCREW. THERE WAS NO PATIENT AND OPERATION INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544551 ↗
• MalfunctionAug 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE INSTRUMENT IN QUESTION WOULD NOT FIT IN THE DRIVER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232208 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, IT WAS FOUND OUT DURING INSPECTION, THE ITEMS WILL NOT RETAIN SCREW ANY LONGER AND THE HOLDING SLEEVE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13516009 ↗
• MalfunctionNov 25, 2019Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS (B)(4) SITE ON AN UNKNOWN DATE, A SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS OBSERVED TO BE A MISSING A PIECE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371192 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION, TWO (2) DEPTH GAUGE FOR 2.0 MM AND 2.4 MM SCREWS TIP WERE BENT AND LOOSE, ONE (1) PERIOSTEAL ELEVATOR 6 MM CURVED BLADE ROUND EDGE HANDLE WAS CRACKING, ONE (1) SCREWDRIVER BLADE WITH HOLDING SLEEVE SHORT DRIVER GETS STUCK IN THE HOLDER, ONE (1) TORQUE LIMITING ATTACHMENT HAS A MISSING TIP, ONE (1) TRIGGER HANDLE / CABLE CUTTER HAS A MISSING PIECE IN THE HANDLE, AND ONE (1) T-HANDLE WOULD NOT GO BACK / STAY TOGETHER, LIKELY MISSING PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5 MM/2.0 MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9238277 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION OF A LOANER SET, THE 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE WOULD NOT MATE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 FO 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8750875 ↗
• MalfunctionMay 7, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A SCREWDRIVER SHAFT CRUCIFORM WITH HOLDING SLEEVE WAS BROKEN WHEN REMOVING A 2.0 SCREW DURING AN ORTHOPEDIC PROCEDURE. IT WAS A SCREW REMOVAL CASE AS FRACTURE WAS HEALED. THERE WAS NO FRAGMENT GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: 2.0 SCREW (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587241 ↗
• MalfunctionDec 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN FRACTURE REPAIR, A HANDLE WITH MINI QUICK COUPLING WAS NOT LOCKING INTO THE HANDLE. IT WAS NOTED THAT IT FITS ON THE SHAFT FINE, BUT THE SLEEVE WILL NOT GRASP. THE ISSUE HAPPENED DURING THE INITIAL IMPLANT SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY SIXTY (60) MINUTES. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT IS FOR ONE (1) SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8189834 ↗