Arthrex® AR-1928SNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867023772), received between Dec 26, 2019 and Jul 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2020Patient-Device Incompatibility

  DURING (B)(6) 2019 A PATIENT HAD REPORTED HAVING POSSIBLE REACTION ISSUES TO ARTHREX AR-1928SNF, CORKSCREW SUTURE ANCHORS THAT HAD BEEN IMPLANTED (B)(6) 2016. THE PRIOR REPORT HAS BEEN RECORDED IN THE ARTHREX SYSTEM UNDER REFERENCE: CASE (B)(4) AND WAS REPORTED TO THE FDA (1220246-2019-01534) ON 12/26/2019. THE PATIENT HAS NOTIFIED ARTHEX THAT SHE WAS LATER REFERRED TO THE MAYO CLINIC WHERE SHE UNDERWENT SURGERY ON (B)(6) 2020 DURING WHICH THE NEW SURGEONS REMOVED THE TWO ARTHREX IMPLANTS AND ALSO REPAIRED AN ABDUCTOR TENDON TEAR. THE IMPLANTS WERE GIVEN TO THE PATIENT. THE PATIENT IS CURRENTLY RECOVERING FROM THE SURGERY AND IS HOPEFUL THAT SHE WILL BE ABLE TO RESUME WALKING AND THAT THE PAIN WILL CONTINUE TO DECLINE.

  Patient problems: No Code Available; Pain

  MAUDE report 10217671 ↗
• InjuryDec 26, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDUCTOR TENDON REPAIR ON (B)(6) 2016 WHERE TWO CORKSCREW SUTURE ANCHORS, AR-1928SNF, WERE IMPLANTED INTO HER LEFT HIP. ABOUT FOUR MONTHS POST-OP, THE PATIENT STARTED TO NOTICE PAIN IN HER HIP. AND HER SKIN WAS TENDER TO THE TOUCH OVER THE SURGICAL SITE. SHE HAS SEEN HER SURGEON MULTIPLE TIMES POST-OP AND HAS TRIED PHYSICAL THERAPY AND PAIN MANAGEMENT TO TRY AND GET THE PAIN UNDER CONTROL. SHE HAS ALSO TRIED OTC MEDICATIONS SUCH AS, TYLENOL AND ASPIRIN, HIP BRACES, TOPICAL PAIN SPRAYS, CREAMS AND OINTMENTS; ALL WITH NO RELIEF. SHE WAS THEN PRESCRIBED TRAMADOL 50MG THREE TIMES A DAY WHICH HE HAS BEEN ON FOR ABOUT A YEAR. SINCE THE START OF HER PAIN, THE SYMPTOMS HAVE NOW INCREASED TO INSTABILITY AND MUSCLE ATROPHY. SHE HAS REACHED OUT TO THE SURGEON AND HAS AN APPOINTMENT ON FRIDAY, (B)(6) 2019. SHE DESCRIBES HER PAIN AS WHITE HOT WITH WEIGHT BEARING AND ALSO AT REST. SHE HAS ALSO BEEN REFERRED TO SPECIALISTS AND THEY HAVE RULED OUT ALL OTHER CAUSES OF THE PAIN. PATIENT FURTHER REPORTED THE PROBLEM HAS CONTINUALLY GOTTEN WORSE OVER TIME AND DUE TO THE INSTABILITY SHE HAS SUFFERED MULTIPLE FALLS WITH SOME RESULTING IN INJURIES SUCH AS A C

  Patient problems: Concussion; Fall; Injury; Pain; Reaction

  MAUDE report 9519491 ↗