Arthrex® AR-1922PSM-1Recalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, PEEK PUSHLOCK SP · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867022980), received between Sep 10, 2020 and Sep 10, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.
Most reported problems
Device problems
- Difficult to Remove2
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.
InjurySep 10, 2020Difficult to Remove
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE SURGEON WAS MALLETING IN THE PUSHLOCK. ON CORRECT REMOVAL, THE TIP OF THE ANCHOR STAYED IN THE BONE BUT THE SCREW CAME OUT. SURGEON WAS NOT ABLE TO REMOVE THE TIP OF THE ANCHOR, IT WILL REMAIN INSIDE OF THE PATIENT. TWO AR-1922PSM-1 W / BATCHES 10625897 AND 10401450 WERE USED DURING THE SURGERY. IT'S NOT POSSIBLE TO DETERMINE WHICH BATCH FAILED DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 4.75 SP SWIVELOCK. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10515583 ↗InjurySep 10, 2020Difficult to Remove
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE SURGEON WAS MALLETING IN THE PUSHLOCK. ON CORRECT REMOVAL, THE TIP OF THE ANCHOR STAYED IN THE BONE BUT THE SCREW CAME OUT. SURGEON WAS NOT ABLE TO REMOVE THE TIP OF THE ANCHOR, IT WILL REMAIN INSIDE OF THE PATIENT. TWO AR-1922PSM-1 W / BATCHES 10625897 AND 10401450 WERE USED DURING THE SURGERY. IT'S NOT POSSIBLE TO DETERMINE WHICH BATCH FAILED DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 4.75 SP SWIVELOCK. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10515562 ↗
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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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