Arthrex® AR-2922PSRecalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867027992), received between Jan 9, 2023 and Dec 24, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Material Fragmentation1
Patient problems
- Failure of Implant2
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Break; Break
IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE ANCHOR BROKE OFF DURING INSERTION. NO PART OF THE DEVICE REMAINED INSIDE 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 23888179 ↗MalfunctionJul 22, 2024Break; Break
ON 12/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-2922PS PEEK PUSHLOCK ANCHORS BROKE AT THE SAME SPOT EACH TIME. THIS WAS DISCOVERED DURING A REVISION POSTERIOR LABRAL REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 12/20/2022: ALL BROKEN FRAGMENTS FROM THE THREE PUSHLOCK'S WERE REMOVED. CASE WAS COMPLETED WITH ANOTHER AR-2922PS PEEK PUSHLOCK. DURING THIS REVISION SURGERY, ONLY THE PUSHLOCK WAS IMPLANTED, AND NOTHING WAS EXPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM ANY INFORMANT REGARDING THE ORIGINAL SURGERY, AS IT WAS PERFORMED BY ANOTHER SURGEON. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19792370 ↗MalfunctionFeb 16, 2023Break
IT WAS REPORTED THAT DURING A LABRUM REPAIR SURGERY ON THE HIP THE PEEK TIP BROKE OFF BY ITSELF AND COULD NOT BE RELOADED. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. 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: Foreign Body In Patient
MAUDE report 16385139 ↗InjuryJan 9, 2023Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-2922PS PEEK PUSHLOCK ANCHORS BROKE AT THE SAME SPOT EACH TIME. THIS WAS DISCOVERED DURING A REVISION POSTERIOR LABRAL REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: ALL BROKEN FRAGMENTS FROM THE THREE PUSHLOCK'S WERE REMOVED. CASE WAS COMPLETED WITH ANOTHER AR-2922PS PEEK PUSHLOCK. DURING THIS REVISION SURGERY, ONLY THE PUSHLOCK WAS IMPLANTED, AND NOTHING WAS EXPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM ANY INFORMANT REGARDING THE ORIGINAL SURGERY, AS IT WAS PERFORMED BY ANOTHER SURGEON.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 16120380 ↗InjuryJan 9, 2023Break; Material Fragmentation
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-2922PS PEEK PUSHLOCK ANCHORS BROKE AT THE SAME SPOT EACH TIME. THIS WAS DISCOVERED DURING A REVISION POSTERIOR LABRAL REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: ALL BROKEN FRAGMENTS FROM THE THREE PUSHLOCK'S WERE REMOVED. CASE WAS COMPLETED WITH ANOTHER AR-2922PS PEEK PUSHLOCK. DURING THIS REVISION SURGERY, ONLY THE PUSHLOCK WAS IMPLANTED, AND NOTHING WAS EXPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM ANY INFORMANT REGARDING THE ORIGINAL SURGERY, AS IT WAS PERFORMED BY ANOTHER SURGEON.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 16120376 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- 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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