Arthrex® AR-2923PS-1Recalls & reported problems
Arthrex, Inc. · SUTR ANCH,PEEK P-LCK,2.9X 12.5MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867280779), received between Oct 12, 2021 and Aug 21, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR BROKE DURING INSERTION. THE BROKEN PART REMAINED EMBEDDED IN THE BONE AND COULD NOT BE RETRIEVED WITHOUT RISK OF FURTHER COMPLICATIONS. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: Foreign Body In Patient
MAUDE report 22860072 ↗MalfunctionFeb 12, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE EYELET BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363937 ↗MalfunctionOct 12, 2021Break
IT WAS REPORTED THAT DURING A LABRUM REFIXATION TWO ANCHORS BROKE OFF WHILE THEY WERE IMPLANTED. THE SURGEON WAS ABLE TO RETRIEVE TO BROKEN PARTS OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ON 23-SEP-21: UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON REPORTED THAT SURGERY WAS SUCCESSFULLY COMPLETED BY THE SURGEON BECAUSE THE LABRUM REFIXATION WAS NOT MANDATORY IN THIS CASE AND THE PATIENT HAD OTHER PATHOLOGIES IN THE JOINT THAT WERE SUCCESSFULLY TREATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12616332 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- 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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