NA 03.507.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587014142), received between May 4, 2020 and Sep 4, 2026 — 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 18, 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.

• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50618629 ↗
• 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) PUNHO EM T PEQ C/ENC-HEX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121379 ↗
• MalfunctionMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT A HIGH ANTERIOR RESECTION PROCEDURE. DURING THE PROCEDURE, A T-HANDLE SMALL WITH HEXAGONAL WAS NOT RETAINING THE REDUCTION TOOL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN REDUCTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10066843 ↗
• MalfunctionMay 4, 2020Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2020, THE TWO (2) TRAYS; MATRIX MANDIBLE AND MATRIX MIDFACE TRAY WERE INSPECTED BECAUSE THE TRAYS HAD FALLEN FROM A SHELF IN THE STERILE PROCESSING DEPARTMENT (SPD). SEVERAL PARTS WERE NOTED TO BE DAMAGED IN THE TRAY. ONE (1) BONE REDUCTION FORCEP HAD A BROKEN FINE TIP, ONE (1) SCREWDRIVER HANDLE WAS BROKEN END CAP IS MISSING, ONE (1) MATRIXMANDIBLE DRILL GUIDE BROKEN TIP DAMAGE ON WHICH THE DRILL BIT WOULD NOT EASILY SLIDING THROUGH, AND ONE (1) T-HANDLE WAS BROKEN SLIDE IS VERY LOOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020851 ↗