Arthrex® AR-1928SF-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867023727), received between Jun 28, 2017 and Aug 9, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE UPPER PART OF THE TIP BROKE OFF. IT WAS NOT POSSIBLE TO INSERT THE IMPLANT INTO THE SCLEROTIC BONE. THE PARTIALLY INSERTED ANCHOR WAS SUCCESSFULLY REMOVED. IT WAS MENTIONED THAT THE INITIAL HAMMERING COULD HAVE LEAD TO THE BREAKAGE. 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 17489242 ↗
• MalfunctionAug 17, 2021Break

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON INSERTED AR-1928SF-3 LOT: 13256588 SUTURE ANCHOR, INTO THE HUMERUS AS HE WAS SCREWING DOWN THE SUTURE ANCHOR THE IMPLANT BROKE IN HALF. THE SURGEON USED A SECOND AR-1928SF-3, SAME LOT NUMBER AND THE SAME ISSUE OCCURRED. ALL BROKEN FRAGMENT WERE REMOVED. THE SURGEON USED A PUNCH AND TAP IN THE SAME INSERTION SITE, THE CASE WAS COMPLETED BY INSERTING 2-ADDITIONAL AR-1928SF-3 SUTURE ANCHORS DIFFERENT LOT NUMBERS.

  Patient problems: Failure of Implant

  MAUDE report 12333137 ↗
• InjuryJun 16, 2020Improper or Incorrect Procedure or Method

  DURING A ROTATOR CUFF REPAIR PROCEDURE IT WAS DISCOVERED THE SUTURE ANCHOR ONLY HAD TWO SUTURES INSTEAD OF THREE. A SECOND HOLE WAS DRILLED AND ANOTHER CORKSCREW WAS USED TO SECURE THE AREA. THE DOCTOR DECIDED TO USE A SECOND IMPLANT BECAUSE THERE WAS ONLY TWO SUTURES ON THE FIRST. HE WAS VERY SATISFIED ALL WAS SECURE AFTER THE SECOND WAS IMPLANTED. THE CASE WAS CONTINUED AND COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10157841 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, ON (B)(6) 2020, THE FOLLOWING INCIDENT OCCURRED: POST IMPLANTATION OF AN AR-1928SF-3 (LOT 10331327), TRIPLE LOADED CORKSCREW, THE SURGEON PASSED ALL SUTURES THROUGH THE ROTATOR CUFF. SURGEON TIED THE FIRST SET, WHICH WAS FINE. SURGEON THEN TIED THE SECOND SET OF SUTURES AND THE #2 FIBERWIRE BROKE AT THE KNOT STACK. SURGEON WENT TO TRANSFER THE THIRD SET OF SUTURES THROUGH THE PASSPORT AND UPON RETRIEVING AND PULLING ADEQUATE TENSION, THE SUTURE SNAPPED IN THE JOINT. THE SURGEON USED THE CORKSCREW AS A TRACTION DEVICE, PASSED A FIBERTAPE THROUGH THE REMAINING PIECE OF ROTATOR CUFF THAT NEED TO BE SECURED AND IMPLANTED SPEED FIX TECHNIQUE WITH A SWIVELOCK. THE TECHNIQUE WAS CHANGED FROM A SUTURE BRIDGE TO A KNOTLESS TECHNIQUE DUE TO THE ISSUE THAT OCCURRED. THE REP REPORTED THAT THE SURGEON FELT THAT THE IMPLANT ACTED AS A TRACTION STITCH AND USED IT TO AID IN HIS KNOTLESS TECHNIQUE. ALL FIBERWIRE THAT BROKE WAS RETRIEVED FROM THE PATIENT. THE ACTUAL IMPLANT ITSELF WAS FINE AND LEFT IN THE PATIENT. IT HAD BEEN IMPLANTED WITH THE CORRECT TECHNIQUE. THE SLIDING SUTURE WAS THE ISSUE. THE FACILITY DISCARDED THE SUTURES THAT WER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10108925 ↗
• InjuryFeb 25, 2020Loose or Intermittent Connection; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT APPROXIMATELY 3 YEARS AGO HE HAD UNDERGONE A ROTATOR CUFF REPAIR SURGERY DURING WHICH AN ARTHREX SCREW WAS IMPLANTED. PATIENT HAD BEEN DOING FINE SINCE THE SURGERY WITH FULL RANGE OF MOTION AND NO PAIN. APPROXIMATELY 4-6 WEEKS PRIOR TO THIS REPORT PATIENT BEGAN HAVING PAIN, INTERNAL BLEEDING AND FORMED A LARGE HEMATOMA ON HIS UPPER ARM. IT WAS DISCOVERED VIA X-RAY THAT THE SCREW WAS NO LONGER IN THE BONE AND WAS LOOSE IN HIS UPPER ARM. THE PATIENT REPORTS HE DID NOT SUFFER ANY INJURY OR TRAUMA THAT MAY HAVE CAUSED TO IMPLANT TO MIGRATE AND COME OUT OF THE BONE. THE SURGEON WILL PERFORM A SECOND SURGERY TO REMOVE THE LOOSE SCREW. THE SECOND SURGERY IS SCHEDULED FOR (B)(6) 2020. THE PATIENT HAS REQUESTED THAT THE EXPLANTED DEVICE BE GIVEN TO HIM AFTER SURGERY. AT TIME OF INITIAL REPORT THE PATIENT DID NOT HAVE THE ACTUAL PART NUMBER OF THE IMPLANT BUT WILL OBTAIN AND PROVIDE. ADDITIONAL INFORMATION OBTAINED 01/10/2020: PATIENT REPORTS THE FOLLOWING: REVISION SURGERY TOOK PLACE (B)(6) 2020, BY SAME SURGEON, AT SAME FACILITY. THE SURGEON REMOVED THE LOOSE SCREW WITH NO COMPLICATIONS. PATIENT REPORTS HEALING IS GOING WELL, ALTHOUGH THE SHOULDER IS SOR

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 9750594 ↗
• InjuryJun 28, 2017Failure To Adhere Or Bond; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN ECLIPSE IMPLANT INTO THE LEFT SHOULDER WITH THE FOLLOWING DEVICES USED DURING PROCEDURE: AR-9345-17, LOT 1611019 (CC116424-LINE 195649); AR-9300-45CPC, LOT 150083212(CC116424-LINE 195661); , AR-9301-02, LOT 150073614 (CC116424-LINE 195663); AND AR-1928SF-3, LOT 10020391 (CC116424-LINE 195664); ALONG WITH A NON ARTHREX GLENOID. THE IMPLANTS GOT DISLOCATED DUE TO A TENDON THAT DID NOT ADHERE IT. THE DECISION WAS MADE TO REVISE IT WITH A REVERSE IMPLANT IN 2017. DURING THE REVISION SURGERY WHEN THE SHOULDER WAS OPENED THE SURGEON FOUND PUS AND THE ECLIPSE IMPLANTS WERE LOOSE IN THE JOINT. PATHOLOGICAL INVESTIGATION DID NOT FIND ANY LAB CULTURE BUT A FOREIGN BODY REACTION /ALLERGIC REACTION WAS DIAGNOSED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: INFORMATION RECEIVED THAT THE COMPLAINT DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE FACILITY. DATE OF THE INITIAL SURGERY WAS ON (B)(6) 2017, DATE OF SECOND SURGERY/REVISION WAS ON (B)(6) 2017.

  Patient problems: Foreign Body In Patient; Purulent Discharge; Reaction

  MAUDE report 6672699 ↗