NA 03.505.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587013947), received between Mar 28, 2017 and Oct 1, 2021 — classified as 2 malfunctions.

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 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.

• MalfunctionOct 1, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, THE EXTRACTION SCREW, HAND REAMER, AND SCREWDRIVER DID NOT WORK AS INTENDED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 0.25MM SLOTTED SCREWDRIVER BLD HEX COUPLING. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12564234 ↗
• MalfunctionMar 28, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE SCREW DRIVER WAS BROKEN DURING THE SURGERY ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT AND SURGICAL OUTCOME, SURGICAL PROLONGATION OR UNKNOWN IF A FRAGMENT FELT INTO THE PATIENTS BODY. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6440798 ↗