NA 313.842Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587036878), received between Jan 17, 2018 and Jan 16, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT TIP OF THE DEVICE WAS TWISTED/TORQUED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094656 ↗
• 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 2.0MM SCREWDRIVER BLADE/SELF- RETAINING/STARDRIVE(TM)/SHORT. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123076 ↗
• MalfunctionDec 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INITIAL IMPLANT TO REPAIR A FRACTURE, 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. IT WAS ALSO REPORTED THAT THE SCREWDRIVER WAS NOT GRABBING SCREWS.THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY SIXTY (60) MINUTES. THERE WAS NO IMPACT TO THE PATIENT. IT WAS FURTHER REPORTED THAT DEVICES WERE NOT WORKING APPROPRIATELY SINCE THEY HAVE HAD THEM. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Patient Involvement

  MAUDE report 8189837 ↗
• MalfunctionJan 17, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 2.0MM SCREWDRIVER BLADE-SELF-RETAINING-STARDRIVE-SHORT WAS FOUND STRIPPED IN THE REPROCESSING AREA WITHOUT ANY INFORMATION. IT IS UNKNOWN WHEN THE MALFUNCTION OCCURRED OR IF THERE IS PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7201594 ↗