Arthrex® AR-13974NRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867015791), received between Oct 26, 2018 and Aug 18, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13974NR FIBER TAPE RETRIEVER BROKE DURING A SHOULDER SCOPE. THE TIP BROKE OFF IN THE JOINT. THE SURGEON IDENTIFIED AND RETRIEVED THE TIP. THE CASE WAS COMPLETED AS USUAL WITH NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250097 ↗
• MalfunctionAug 15, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13974NR FIBERTAPE RETRIEVER TIP BROKE OFF. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15223789 ↗
• MalfunctionMar 14, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13974NR FIBER TAPE RETRIEVE TIP BROKE INSIDE THE PATIENTS SHOULDER. SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENT. THIS WAS DISCOVERED DURING A CUFF MEND REPAIR ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 13757193 ↗
• MalfunctionDec 27, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13974NR FIBER TAPER RETRIEVER HAD THE TIP BROKEN OFF DURING A CASE. ALL WAS RETRIEVED. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 13087841 ↗
• InjuryOct 26, 2018Break; Entrapment of Device; Device Fell

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE ROTATOR CUFF REPAIR PROCEDURE, AFTER THE SURGEON IMPLANTED THE MEDIAL ROW ANCHORS AND WAS PASSING SUTURE THROUGH THE CUFF, THE ROUNDED END OF THE AR-13974NR, FIBERTAPE GRASPER BROKE OFF INTO THE SUBACROMIAL SPACE WITHIN THE SUBACROMIAL BURSA AND OTHER SOFT TISSUES. THE TIP BROKE OFF AS THE SURGEON WAS RETRIEVING SUTURE AND PULLING SUTURE OUT OF THE CANNULA. X-RAYS WERE THEN ORDERED TO TRY AND LOCATE THE BROKEN FRAGMENT. AS THE SURGEON WAS WAITING ON X-RAY TECHNICIANS, THE SURGEON WENT ON TO COMPLETE THE BICEPS TENODESIS PORTION OF THE PROCEDURE. THE REP STATED THAT THE BROKEN TIP WAS CLEARLY VISIBLE ON X-RAY, BUT THE SURGEON WAS HAVING A HARD TIME PHYSICALLY LOCATING THE BROKEN FRAGMENT. THE REP STATED FIRST, A MINI C-ARM WAS USED TO CONFIRM THE BROKEN PIECE WAS IN FACT STILL IN THE SHOULDER AND TO SPECIFICALLY LOCATE FOR RETRIEVAL. AFTER 10-15 MINUTES OF UNSUCCESSFUL ATTEMPTS TO RETRIEVE VIA THE SCOPE PORTALS THE SURGEON BRIEFLY TRIED TO VIEW WITH THE SCOPE, BUT WAS RELUCTANT TO DO SO WITH FLUID ON AS HE DID NOT WANT THE ITEM TO BE FLUSHED AROUND TO MAKE IT POTENTIALLY HARDER TO LOCATE. AT THIS TIME HE MADE THE DECISION TO TRANSITION TO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8008767 ↗