Arthrex® AR-2922BC-1Recalls & reported problems
Arthrex, Inc. · SUTR ANCH, BIO-COMP P - LCK, 2.4 X 11.3 · Class 2 · Implant
Data updated Oct 18, 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 00888867197633), received between Nov 21, 2024 and Apr 25, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Split, Cut or Torn1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Break; Break
IT WAS REPORTED THAT DURING A BANKART SURGERY THE ANCHOR BROKE AT THE END OF THE ANCHOR WHEN INSERTING THE DEVICE INTO THE GLENOID. THESE PARTICLES COULD BE COMPLETELY REMOVED BY THE SUCTION ON THE SHAVER. THE ANCHOR ITSELF HELD AND WAS USED TO FINISH THE PROCEDURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21909396 ↗MalfunctionApr 25, 2025Break; Break
IT WAS REPORTED THAT DURING A BANKART SURGERY THE EYELET OF THE ANCHOR BROKE WHEN THREADING THE SUTURE. 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 21909359 ↗MalfunctionApr 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A BANKART SURGERY THE ANCHOR BROKE AT THE END OF THE ANCHOR WHEN INSERTING THE DEVICE INTO THE GLENOID. THESE PARTICLES COULD BE COMPLETELY REMOVED BY THE SUCTION ON THE SHAVER. THE ANCHOR ITSELF HELD AND WAS USED TO FINISH THE PROCEDURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909330 ↗MalfunctionNov 21, 2024Break; Positioning Failure; Break; Positioning Failure
IT WAS REPORTED THAT DURING A LABRUM REFIXATION WITH BICEPS SURGERY THE IMPLANT DID NOT HOLD IN THE PATIENT AND GOT FRAYED AT THE END. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 20749096 ↗
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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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