Arthrex® AR-1926PS-1Recalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5 MM · 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 00888867023345), received between Nov 28, 2022 and Jan 13, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE IMPLANT BROKE WHILE BEING SCREWED INTO A PRE-DRILLED HOLE CAUSING THE SUTURE BREAKAGE. 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 24053636 ↗MalfunctionMay 6, 2024Break; Break
USING THE 3.5 PUSHLOCK AR-1926PS-1 FOR SECOND ROW SUTURE. THE SUTURES WERE LOADED INTO THE IMPLANT AND IT WAS PUNCHED INTO THE BONE. WHEN PULLING THE ANCHOR OUT THE SUTURES CAME WITH IT AND THE SCREW STAYED IN THE BONE. A NEW PUSHLOCK NEEDED TO BE OPENED AND A NEW HOLE CREATED TO COMPLETE REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19247970 ↗MalfunctionMar 21, 2023Break; Break
IT WAS REPORTED THAT DURING SHOULDER SURGERY, THE ANCHOR BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16582253 ↗MalfunctionNov 28, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A PUSHLOCK ANCHOR FELL APART WHEN BEING IMPACTED INTO A PATIENT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022. THE EYELET SEPARATED FROM THE ANCHOR AND WAS UNABLE TO BE RETRIEVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW PUSHLOCK DEVICE WITH NO PATIENT EFFECT REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 15868264 ↗
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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