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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

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