Arthrex® AR-1973ERecalls & reported problems
Arthrex, Inc. · BIO-TRANSFIX EXTRACTION PIN · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867024656), received between Mar 23, 2018 and Mar 23, 2018 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2018Break
IT WAS REPORTED THAT DURING A CASE, AS THE SURGEON WAS ATTEMPTING HARDWARE REMOVAL USING THE ACL REVISION KIT, THE TIP OF THE BIO-TRANS FIX EXTRACTOR BROKE WHILE TRYING TO REMOVE ANOTHER MANUFACTURER'S CROSS PIN PRODUCT. THE TIP OF THE EXTRACTOR WAS NOT RETRIEVED. FOLLOW-UP INVESTIGATION: THE CASE WAS AN ACL REVISION THE TIP WAS NOT REMOVED AND NO X RAY WAS TAKEN. BECAUSE THE FEMORAL CROSS PIN COULD NOT BE REMOVED, THE SURGEON DID AN OVER THE TOP ACL INSTEAD OF THE PLANNED TECHNIQUE.
Patient problems: No Information
MAUDE report 7365028 ↗
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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 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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