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USS 388.357Recalls & reported problems

Synthes GmbH · LOCKING RING EXTRACTOR FOR USS VARIABLE AXIS SCREWS · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034772547), received between Oct 25, 2019 and Oct 25, 2019 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Code Available1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryOct 25, 2019Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE HEXAGONAL SCREWDRIVER SHAFT AND THE LOCKING RING EXTRACTOR FOR USS WERE BROKEN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND HOW IT WAS COMPLETED. TIME IN SURGERY WAS EXTENDED TWO TO THREE HOURS AS INSTRUMENTS FROM ANOTHER SET WERE USED TO EXTRACT IMPLANTS. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN.

    Patient problems: No Code Available; No Consequences Or Impact To Patient

    MAUDE report 9239239 ↗

Other TRAY, SURGICAL, INSTRUMENT devices

All TRAY, SURGICAL, INSTRUMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.