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NA 388.143Recalls & reported problems

Synthes GmbH · INTERNAL COUNTERTORQUE WITH T-HANDLE · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034772035), received between May 14, 2018 and May 14, 2018 — classified as 1 malfunction.

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 Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 14, 2018Break; Break

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SPINAL FUSION SURGERY PERFORMED ON (B)(6) 2018, THE SOCKET-WRENCH BROKE. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGERY WAS FINISHED WITHOUT DELAY AS SECOND DEVICE WAS PRESENT IN THE SET. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7512265 ↗

Other WRENCH devices

All WRENCH devices →

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