NA 03.043.012SRecalls & reported problems
Synthes GmbH · TROCAR / LONG FOR NAILS Ø 8-13MM / STERILE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10886982298928), received between Jan 23, 2024 and Jan 23, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2024Break; Break
IT WAS REPORTED DURING A SURGERY TO EXPLORE THE KNEE ON (B)(6) 2024, THE TIP OF A SUPRAPATELLA TROCAR WAS SUCCESSFULLY REMOVED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT IS FOR ONE TROCAR / LONG FOR NAILS 8-13 / SILE FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4). THIS REPORT IS FOR THE POST OPERATIVE PAIN REPORTED IN (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18562812 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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