Arthrex® AR-1928SF-2-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867023710), received between Mar 29, 2019 and Sep 9, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE IMPLANT FELL OUT OF THE BONE DURING SUTURE TIGHTENING. 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 23000600 ↗
• MalfunctionFeb 6, 2025Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE THREADS IN THE ANCHOR WERE WORN. 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. UPDATE AVOE 30-JAN-2025: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321158 ↗
• MalfunctionNov 9, 2022Break

  ON THE (B)(6) 2022, IT WAS REPORTED BY THE SALES REP THAT THE SURGEON WAS DOING HIS STANDARD ROTATOR CUFF REPAIR USING A 5.5MM SUTURE ANCHOR, CORKSCREW FT II. THE SURGEON HAD ALREADY INSERTED 2 OF THEM SUCCESSFULLY. HOWEVER, WHEN THE THIRD ANCHOR WAS PLACED IN THE MEDIAL ROW, AFTER HE HAD PASSED THE SUTURES & TIED HIS KNOTS, THE SUTURE EYELET INSIDE THE ANCHOR THAT CONTAINS THE SUTURES BROKE. THE SMALL WHITE SUTURE EYELET COMING OUT OF THE ANCHOR BROKEN WAS VISIBLE. THE SURGEON MENTIONED THIS WAS THE SECOND TIME IN A FEW WEEKS THE SAME ISSUE HAD OCCURRED. HE WAS UNABLE TO REMOVE THE ANCHOR, THE METAL ANCHOR REMAINS INSITU. ANOTHER CORKSCREW ANCHOR WAS PLACED OVER THE TOP OF THE EXISTING ANCHOR WHICH WAS SUCCESSFUL, AND THE REPAIR COMPLETED IN HIS STANDARD TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758726 ↗
• InjurySep 6, 2022Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE SUTURE OF THE DEVICE WAS LOOSE AFTER SCREWING. ALL PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A SUTURETAK AND A SWIVELOCK BY SWITCHING THE SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE (B)(6) 2022 IT WAS CONFIRMED THAT ONLY THE SUTURE OF THE DEVICE WAS LOOSE AND TORE. NO OTHER BREAKAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362666 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2016 A LABRUM-FIXATION WITH FIBERTAK 1.5 TIGERWIRE WAS PERFORMED WITH PATIENT. SINCE THIS SURGERY SHE SUFFERS FROM INVALIDATING PAIN, ESPECIALLY IN THE AREA OF THE SUPRASCAPULAR NERVE AND THE BRACHIAL PLEXUS. UPDATE 22-FEB-2019: THE PATIENT WAS OPERATED FOR A SIMPLE SLAP (SUPERIOR LABRUM FROM ANTERIOR TO POSTERIOR) LESION WITH BICEPS TENODESIS (1X CORKSCREW) AND REFIXATION OF THE POST LABRUM WITH 2 FIBERTAK`S . POST-OP THE PATIENT SHOWED CLASSIC RESIDUAL SYMPTOMS LIKE A CAPSULITIS. EVEN THOUGH THE PATIENT SHOWED SIGNS OF CAPSULITIS, THE SURGEON DOES NOT THINK THAT IT IS CAUSED BY THE ARTHREX DEVICE. ACCORDING TO THE SURGEON THE PATIENT IS HYPERREACTIVE AND EXTREMELY SKEPTICAL. IN THE MEANTIME, SHE HAS BEEN RE-OPERATED TWICE BY DIFFERENT HOSPITALS/SURGEONS. ACCORDING TO THE PATIENT AFTER EACH SURGERY IT GETS WORSE. UPDATE 11-MAR-2019: THE FOLLOWING ITEMS WERE INVOLVED IN THE SURGERY ON (B)(6) 2016: TWO PIECES AR-1928SF-2-1, LOT NUMBER: 759948 AND 759948. THREE PIECES OF AR-3600 LOT NUMBERS: 1552643 ; 1552643 ; 300375.

  Patient problems: Inflammation; Pain

  MAUDE report 8464084 ↗