Arthrex® AR-13975SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867015838), received between Apr 21, 2017 and Nov 18, 2025 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionNov 18, 2025Break; Break

  ON 11/03/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-13975SR FIBERWIRE GRASPER TIP BROKE OFF. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584324 ↗
• MalfunctionNov 22, 2024Break; Break

  ON 10/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13975SR FIBERWIRE® GRASPER BROKE. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY ON (B)(6) 2024. THE BOTTOM JAW BROKE OFF WHILE INSERTING THE INSTRUMENT INTO THE JOINT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758995 ↗
• MalfunctionDec 27, 2022Material Twisted/Bent; Break; Material Twisted/Bent

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-13975SR FIBERWIRE® GRASPER W/SR HANDLE IS BROKEN AT THE DISTAL END OF THE TIP. THIS OCCURRED DURING A CASE, NO PIECES WERE LEFT IN THE PATIENT, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051575 ↗
• MalfunctionNov 16, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13975SR FIBERWIRE GRASPER, DISTAL END BROKE. THIS WAS DISCOVERED DURING USE IN PROCEDURE ON (B)(6) 2021. ALL FRAGMENT WERE REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12819165 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED THAT DURING A RCR/ BANKART PROCEDURE, THE AR-13975SR BROKE. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-13975SR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872439 ↗
• InjuryApr 21, 2017Break; Detachment Of Device Component; Entrapment of Device; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON WAS USING THE FIBERWIRE GRASPER WITH SR HANDLE TO GRASP THE BICEPS TENDON. THE UPPER JAW OF THE GRASPER BROKE-OFF INTO THE PATIENT'S JOINT. THE SURGEON ATTEMPTED TO LOCATE THE JAW FRAGMENT WITH THE SCOPE HOWEVER, COULD NOT LOCATE IT. THE SURGEON THEN HAD AN X-RAY BROUGHT IN AND WAS ABLE TO CONFIRM THE LOCATION OF THE JAW FRAGMENT BUT WAS UNABLE TO RETRIEVE IT. A SECOND SURGERY IS UNDETERMINED AT THE MOMENT AND THE SURGEON WILL WATCH FOR ANY SYMPTOMS BEING CAUSED BY THE DEVICE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6511012 ↗