OsteoFab Suture Anchor SA002-45Recalls & reported problems
Oxford Performance Materials, Inc. · OsteoFab 4.5mm Suture Anchor · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850004435045), received between Mar 17, 2021 and Dec 1, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Most reported problems
Device problems
- Break3
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2022Break; Break
DISTRIBUTOR REPORTED THAT DURING A RECENT SURGERY, A SURGEON BROKE A 4.5MM ANCHOR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. THERE WAS NO REPORTED HARM TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15897250 ↗MalfunctionJun 6, 2022Break
IT WAS REPORTED THAT DURING SURGERY, TWO 4.5MM ANCHORS WERE BROKEN DURING INSERTION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. THERE WAS NO REPORTED HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14603564 ↗MalfunctionMar 29, 2022Break
OPM SALES DIRECTOR REPORTED THAT THREE 4.5 SIZED SUTURE ANCHORS BROKE DURING A SURGERY HE ATTENDED. THIS WAS THE SURGEON'S FIRST TIME USING THE DEVICE. THE PATIENT WAS A YOUNG WOMAN. PATIENT NAME AND AGE ARE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13942185 ↗MalfunctionMar 17, 2021Fracture
SUTURE ANCHOR FRACTURED WHEN SURGEON ATTEMPTED TO INSERT THE ANCHOR INTO THE PATIENT'S BONE. ALL DEVICE FRAGMENTS WERE RETRIEVED FROM THE SURGICAL SITE AND THERE WAS NO REPORT OF PATIENT INJURY. PROCEDURE WAS COMPLETED WITH ADDITIONAL UNITS OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11504765 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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