NA 313.992Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982188342), received between Apr 19, 2018 and Nov 13, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• 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 1.3MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING. THIS IS REPORT 8 OF 10 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121697 ↗
• MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW DRIVERS WERE STRIPPED. THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.3 CRUC SCREWDRIVER SFT, SELF-RETAINING THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807289 ↗
• MalfunctionDec 18, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, DURING AN INSPECTION, THE TIP OF THE CRUCIFORM SCREWDRIVER SHAFT WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 1.3MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11039741 ↗
• MalfunctionApr 19, 2018Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS FOUND THAT THE TIP OF SCREWDRIVER SHAFT WAS BROKE AND WAS MISSING A BLADE. THE MISSING PIECE WAS LESS THAN 2 MM. IT WAS ALSO REPORTED THAT THE MISSING PIECE OF THE SCREWDRIVER WAS NOT ACCOUNTED FOR AND COULD NOT BE LOCATED. IT WAS UNKNOWN AS TO HOW THE DEVICE BROKE. THERE IS NO PATIENT INVOLVEMENT. THERE IS NO ADDITIONAL INFORMATION PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7445032 ↗