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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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