NA 03.507.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587014173), received between Jul 22, 2021 and Jul 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN ORIF FOR TREATING CHEEK BONE FRACTURE ON (B)(6) 2022. AFTER THE SURGEON MADE A BURR HOLE WITH THE HANDLE AND THE REDUCTION TOOL, REDUCTION WAS ATTEMPTED IN THE LESION. NEXT, HE TRIED TO EXTRACT THE HANDLE AND THE REDUCTION TOOL FROM THE BURR HOLE. HOWEVER, THE REDUCTION TOOL DID NOT TURN WHILE ONLY THE HANDLE TURNED IDLY. HE TOOK TROUBLESHOOTING AND FINALLY MANAGED TO EXTRACT THEM LESS THAN 30-MINUTE SURGICAL DELAY. ACCORDING TO THE SURGEON, HE USED A PLIER TO EXTRACT THE DEVICES DURING THE TROUBLESHOOTING. THE USE OF THE PLIER LEFT SOME SCRATCHES ON THE REDUCTION TOOL¿S TAPPING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)THREAD REDUC TOOL Ø3.5 SELF-TAP L78 W/HE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121407 ↗
• MalfunctionJul 22, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE REDUCTION TOOL BECAME STRIPPED. THIS REPORT IS FOR A 3.5MM THREADED REDUCTION TOOL SELF-TAPPING 78MM HEX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211049 ↗