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NA 388.44Recalls & reported problems

Synthes GmbH · ROD HOLDING FORCEPS FOR 6.0MM RODS · 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 10705034772950), received between Apr 14, 2017 and Apr 14, 2017 — 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
  • Detachment Of Device Component1

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.

  • MalfunctionApr 14, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

    IT IS REPORTED DURING AN INITIAL SCOLIOSIS CORRECTION PROCEDURE ON (B)(6) 2017, ONE SCREW ON THE ROD HOLDING FORCEPS WAS BROKEN INTO TWO (2) PIECES. THE HEAD OF THE BROKEN SCREW FELL ONTO THE FLOOR AND WAS EASILY RETRIEVED. THE SHAFT OF THE BROKEN SCREW REMAINS IN THE ROD HOLDING FORCEPS. IN ADDITION, A SECOND SCREW ON THE DEVICE BECAME LOOSE DURING ROD ROTATION, CAUSING THE SPRING OF THE ROD HOLDING FORCEPS TO COME APART. PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING ANOTHER ROD HOLDING FORCEPS WITH NO DELAY AND NO HARM TO PATIENT. THIS REPORT IS FOR ONE (1) ROD HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6494186 ↗

Other FORCEPS devices

All FORCEPS devices →

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