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BIORCI 7209023Recalls & reported problems

Smith & Nephew, Inc. · BIORCI-HA INTERFERENCE SCREW 7 MM X 25 MM 7 MM STERILE HEAD, REVERSE THREAD · Class 2 · Implant

All models of BIORCI (32)

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 03596010460080), received between Nov 27, 2017 and Nov 27, 2017 — 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.

Most reported problems

Device problems

  • Break1
  • Difficult to Remove1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 27, 2017Break; Difficult to Remove

    IT WAS REPORTED THAT THE SCREW (BIORCI-HA 7X25MM/8MM) BROKE INTO PIECES WHILE BEING ADVANCED INTO FEMORAL TUNNEL. SURGEON MADE ALL EFFORT TO REMOVE BITS AND PIECES OF SCREW, BUT NONE WAS RETRIEVED FOR SAMPLING. SCREW TAP ON-SITE, DID NOT USED. SURGEON ENDED UP USING RCI SCREW FOR THE FEMUR INSTEAD. SCREW IMPLANTED SUCCESSFULLY, PROCEDURE COMPLETED WITHOUT ANY OTHER INCIDENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7059842 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

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