OsteoFab Suture Anchor SA002-55Recalls & reported problems
Oxford Performance Materials, Inc. · OsteoFab 5.5mm Suture Anchor · Class 2 · Implant
Data updated Oct 18, 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 00850004435052), received between Jun 2, 2021 and May 9, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2022Break
SURGEON REPORTED BREAKING THREE 5.5MM OSTEOFAB SUTURE ANCHORS IN SURGERY. THIS WAS THE SURGEONS FIRST TIME USING THE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14341698 ↗MalfunctionJun 2, 2021Break
SALES REP REPORTED QUANTITY 2 OF SIZE 5.5MM ANCHORS BROKE DURING SURGERY: ONE BROKE DURING INSERTION AND ONE BROKE WHEN SURGEON ATTEMPTED TO BACK IT OUT DUR TO A BROKEN SUTURE. DEVICE FRAGMENTS WERE RETRIEVED AND THERE IS NO REPORTED INJURY TO THE PATIENT. PROCEDURE WAS COMPLETED WITH ADDITIONAL UNITS OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11924602 ↗
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- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
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- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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