NA 316.447Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587038056), received between Dec 21, 2016 and Dec 21, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2016Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DRILL TIP WAS BROKEN DURING THE PLATE FIXATION OF MANDIBLE ANGLE. THE SCREW WAS BROKEN DURING THE PLATE FIXATION OF MEDIAN PART. THE SURGEON WAS AWARE THAT THE PRODUCTS WERE NOT RECOMMENDED TO USE FOR MANDIBLE BONE. HOWEVER, THE CUSTOMER SAYS EXCESSIVE FORCE WAS NOT APPLIED DURING THE USAGE. CURRENTLY THE BRAIN CONTUSION IS SEVERE, AND THE PATIENT IS BEING INTUBATED. NO X-RAY WAS SHOT SINCE THE INCIDENT, AND THE BROKEN FRAGMENTS ARE BEING REMAINED IN THE PATIENT¿S BODY. WHEN THE INCIDENT OCCURRED, THE NURSE TOLD SALES REPS THAT ONLY SCREW WAS BROKEN, SO THE BROKEN DRILL WAS NOT TAKEN OUT OF THE PATIENT¿S BODY. THE HOSPITAL OPINIONS THAT THE PRODUCTS EXCEEDED THE LIMIT FOR THE NUMBER OF TIMES OF STERILIZATION, HOWEVER THE CUSTOMER SAYS THAT LIMITATION IS NOT STATED CLEARLY BY THE MANUFACTURE. THERE IS NO INFORMATION AVAILABLE ABOUT SURGICAL OUTCOME. THERE WAS NO SURGICAL PROLONGATION REPORTED. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT DEVICE: 1X UNK SCREWDRIVER. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6197490 ↗