NA 690.504Recalls & reported problems
Synthes GmbH · LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS · Class 1
Data updated Oct 13, 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 10886982254184), received between Jun 30, 2017 and Jun 8, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Appropriate Device Problem Term/Code Not Available1
- Scratched Material1
Patient problems
- No Known Impact Or Consequence 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.
MalfunctionJun 8, 2018Scratched Material; Scratched Material
IT WAS REPORTED THAT DURING A FIELD EQUIPMENT INSPECTION THE LOCKING SCREW RACK WAS FOUND DENTED. THERE IS NO PATIENT INVOLVEMENT. UPON RECEIPT OF THE DEVICE AT MANUFACTURER, IT WAS NOTED THAT THE COATING ON SCREW RACK WAS CHIPPING/PEELING. THIS REPORT IS FOR ONE (1) LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7584430 ↗MalfunctionJun 30, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE BOTTOM EDGES OF THE LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS ARE ROUGH AND SHARP. THE TERRITORY MANAGER WAS LIFTING THE LOCKING SCREW RACK FROM THE TRUNK OF THE CAR AND THE LOCKING SCREW RACK CUT HIM. IT WAS APPROXIMATELY A 2-CM SUPERFICIAL CUT. IT BLED, AND WAS TREATED WITH A BANDAGE. PATIENT DID NOT SEE A DOCTOR. CONCOMITANT DEVICE REPORTED: LID FOR LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS (PART 690.505 , LOT LIF025114, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6680890 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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