NA 313.969Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982188281), received between May 1, 2019 and Sep 9, 2026 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696336 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING REPROCESSING, A SCREWDRIVER WAS SEEN TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381968 ↗
• MalfunctionJan 31, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR 3.0 CANN SCREWDRIVER WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR 3.0 CANN SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392174 ↗
• MalfunctionJan 26, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT DPY (B)(4) SITE, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR 3.0MM CANNULATED SCREWDRIVER WAS FOUND TO BE MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE FOR 3.0MM CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11230912 ↗
• MalfunctionJul 27, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION, THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT AND THE HOLDING SLEEVE FOR CANNULATED SCREWDRIVER WOULD NOT SPRING BACK INTO PLACE. THE CANNULATED AWL HAD PITTING AND DENTS ON THE BLADE. THERE WAS NO PATIENT INVOLVEMENT. DETERMINED TO BE A REPORTABLE MALFUNCTION ON JULY 24, 2020. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE FOR 3.0 MM CANNULATED SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10326128 ↗
• MalfunctionMay 1, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR CANNULATED SCREWDRIVER WAS MISSING A PART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HOLDING SLEEVE FOR CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8569552 ↗