Arthrex® AR-7297Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867289086), received between Jul 31, 2018 and Nov 30, 2021 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021Output Problem

  ON (B)(6) 2021, IT WAS REPORTED THROUGH THE CLINDEX SYSTEM THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT. ADDITIONAL INFORMATION PROVIDED 11/08/2021: ON (B)(6) 2021, IT WAS REPORTED THE SCAB FELL OFF THE INCISION. (2CM X 3 CM WOUND, APPROXIMATELY 1/4 INCH IN DEPTH). A WOUND CULTURE WAS SENT (NEGATIVE). PATIENT WAS ADVISED TO HAVE DAILY WOUND DRESSING CHANGES BY HOME HEALTH. PATIENT RETURNED TO CLINIC ON (B)(6) 2021 FOR A RECHECK, AND WOUND WAS OPENED (8-10CM, DEPTH 1CM). PATIENT WAS ADVISED TO CONTINUE WOUND CARE. ON (B)(6) 2021 PATIENT RETURNED FOR AN OFFICE VISIT, AND THE WOUND WAS (12CM X 2 CM X 1.5CM), AND PLANNED FOR SURGICAL DEBRIDEMENT. ON (B)(6) 2021 PATIENT WAS ADMITTED FOR SURGICAL DEBRIDEMENT. WOUND WAS (16CM X 7 CM X 3CM), AND A WOUND VAC WAS PLACED. A WOUND CULTURE SENT- (B)(6), AND STILL CONSIDERED TO BE SUPERFICIAL. ON (B)(6) 2021 THE WOUND CULTURE RESULT WAS (B)(6), AND THE PATIENT WAS SEEN IN OFFICE ON (B)(6) 2021 WITH HH TO DO DAILY DRESSING CHANGES. ON (B)(6) 2021 PATIENT WAS TAKEN TO THE OR FOR DEBRIDEMENT. DURING THIS PROCEDURE THE SURGEON DEBRIDED DOWN TO STERNUM AND THE FIBERTAPES WERE REMOVED. THE PATIENT IS CONSIDERED TO HAVE A DEEP WOUND INFECTION, AND IS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12896308 ↗
• InjuryJan 30, 2019Break; Failure to Advance; Physical Resistance/Sticking

  IT WAS DISCOVERED DURING MONTHLY SOCIAL SAFEGUARD CYBER REVIEW THAT A CASE DID NOT GO AS PLANNED AND THE SURGEON WAS FORCED TO CUT OUT HIS REPAIR. IN ADDITION A TENSION DEVICE WAS BROKEN. ADDITIONAL INFORMATION OBTAINED 1/7/19: THE SURGEON WAS PERFORMING AN OPEN TSA USING ANOTHER MANUFACTURER'S IMPLANT AND AN ARTHREX FIBERTAPE SUBSCAP COMPRESSION BRIDGE KIT, AR-7297. THE SURGEON WAS UNABLE TO ACHIEVE DESIRED TENSION DURING FIBERTAPE COMPRESSION BRIDGE SUBSCAP REPAIR. HE HAD DIFFICULTY WITH ISSUES WITH THE ARTHREX AR-7297-ST, SUTURE TENSIONER THAT IS A COMPONENT OF THE AR-7297 KIT. IT SEEMED TO SEIZE OR BECOME STUCK DURING FINAL TENSIONING. THE DEVICE WOULD NOT ADVANCE. ONCE THE TAILS WERE PROPERLY LOADED INTO THE DISTAL END OF THE TENSION DEVICE, THE SQUARE HELD AND THE BALL TURNED BUT NOTHING HAPPENED. THE BALL WOULD NOT TURN AND PADDLE WOULD NOT ADVANCE. THE SURGEON FEEDBACK WAS THAT SOMETHING FELT STUCK. THE SUTURES WERE REMOVED FROM THE DEVICE AND THE DEVICE WAS INSPECTED BY THE SURGEON. WHEN THE SURGEON TRIED AGAIN, AWAY FROM THE BODY, HE WAS ABLE TO GET THE DEVICE (AKA SQUARE AND PEAR) TO MOVE FREELY BUT IT WAS NOTICED THAT THE DEVICE WOULD COME APART INTO TWO PIECES. THE RAC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8289646 ↗
• InjuryJul 31, 2018Break; Device Fell

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE AS THE SURGEON WAS ATTEMPTING TO PULL THE TAILS OF THE TAPE ON THE AR-7297 FIBERTAPE COMPRESSION BRIDGE KIT (THAT WERE LOADED INTO THE NITINOL LOOP) THROUGH THE LOOPED ENDS OF THE TAPE, THE NITINOL LOOP BROKE BEFORE THE ENDS OF TAPE WERE PASSED. THE BROKEN BLACK PLASTIC PIECE AND NITNOL LOOP WERE FULLY RETRIEVED AND TOSSED FROM THE STERILE FIELD. THE PROCEDURE WAS COMPLETED AS PLANNED. THE REP STATED THAT THE SURGEON PERFORMS X-RAYS AFTER EVERY PROCEDURE. THE X-RAY TAKEN REVEALED A SMALL METAL PIECE REMAINED IN THE PATIENT. THE PATIENT WAS STILL UNDER ANESTHESIA AND IN THE OPERATING ROOM. THE SURGEON REOPENED THE INCISION AND EXTENDED BY APPROXIMATELY AN INCH IN ORDER TO REMOVE THE BROKEN FRAGMENT. AFTER INSPECTING THE BROKEN METAL PIECE, THE REP CONFIRMED THAT THE PIECE THAT FELL INTO THE INCISION WAS THE SMALL METAL ROD WITHIN THE BLACK PLASTIC PIECE AND NITNOL LOOP. ADDITIONAL INFORMATION RECEIVED 07/10/2018: THE REP STATED THAT THE PROCEDURE WAS COMPLETED BY LOADING THE ENDS OF THE TAPE INTO A FREE NEEDLE, AND PROCEEDED TO PASS THE ENDS THROUGH THE TAPE LOOPS. ADDITIONAL INFORMATION RECEIVED 7/26/2018 VIA FACIL

  Patient problems: No Code Available

  MAUDE report 7734409 ↗