NA 03.118.001Recalls & reported problems
Synthes GmbH · PERIARTIC REDUCTION FORCEPS 6.5MM BALL & POINTED TIP/SM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982073303), received between Dec 7, 2017 and Oct 9, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Break2
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A PERIARTIC REDUCTION FORCEPS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PERIARTIC REDUCTION FORCEPS 6.5 MM BALL & POINTED TIP/SM. THIS IS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9170279 ↗MalfunctionDec 7, 2017Break; Difficult to Remove; Break; Difficult to Remove
IT WAS REPORTED THAT DURING AN UNKNOWN ANKLE RECONSTRUCTION PROCEDURE ON (B)(6) 2017, THE SURGEON UTILIZED A SYNTHES 6.5MM BALL & POINTED TIP, SMALL PERIARTICULAR REDUCTION FORCEPS TO REDUCE THE FRACTURE. AFTER IMPLANTING ADDITIONAL DEVICES, THE SURGEON ATTEMPTED TO REMOVE THE REDUCTION FORCEPS; HOWEVER, THE DEVICE WOULD NOT LOOSEN. THE SURGEON THEN USED AN UNKNOWN PAIR OF VICE GRIPS PLIERS TO LOOSEN THE NUT AND THE NUT SUBSEQUENTLY BROKE. THE BROKEN PIECE AND THE REDUCTION FORCEPS WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO ADVERSE EVENTS WERE REPORTED. CONCOMITANT DEVICES REPORTED: VICE GRIPS PLIERS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7097219 ↗
Other FORCEPS devices
- NA 314.291Synthes GmbH · FORCEPS177 reports
- NA 399.99Synthes GmbH · FORCEPS111 reports
- NA PDL114Synthes GmbH · FORCEPS81 reports
- GEM COUPLER Forceps GEM4183CSynovis Micro Companies Alliance, Inc · FORCEPS1 recall4 reports
- AESCULAP BJ080RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ130RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ132RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ045RAesculap AG · FORCEPS1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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