NA 391.88Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982198334), received between Apr 2, 2017 and Mar 17, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 17, 2020Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THAT THE PLIERS WERE OBSERVED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES LOCKING PLIERS 180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9843352 ↗
• MalfunctionSep 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A CUSTOMER HAS A NUMBER OF INSTRUMENTS THAT ARE NOT FUNCTIONING CORRECTLY. LOCKING PLIERS HAS A JAW HAS LIMITED RANGE OF MOTION AND ALSO CANNOT LOCK. A T-HANDLE, QUICK COUPLING IS NOT GRIPPING ONTO TAP PROPERLY. A COUNTERSINK SCREWDRIVER IS CHIPPED WITH A WARPED SCREW HEAD. NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108825 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION AT FIELD STOCKING LOCATION ((B)(4)), IT WAS OBSERVED THAT THE LOCKING PLIERS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8749525 ↗
• MalfunctionApr 2, 2017Break; Break

  DEVICE REPORT FROM (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE 180 MM LOCKING PLIERS HAVE A BROKEN SUPPORT. IT IS UNKNOWN WHEN THE INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OR PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6452488 ↗