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NA 399.57Recalls & reported problems

Synthes GmbH · CHISEL BLADE 25MM · 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 10886982202949), received between Nov 5, 2018 and Nov 5, 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 Patient Involvement1

Recent adverse event reports

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

  • MalfunctionNov 5, 2018Break; Break

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN PC-(B)(4) (10 DEVICES), PC-(B)(4) (10 DEVICES), PC-(B)(4) (10 DEVICES). THIS REPORT IS FOR ONE (1) 25MM CHISEL BLADE. THIS IS REPORT 8 OF 8 FOR COMPLAINT PC-(B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8039619 ↗

Other CHISEL, SURGICAL, MANUAL devices

All CHISEL, SURGICAL, MANUAL devices →

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