Arthrex® AR-7250Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867041851), received between Dec 21, 2020 and Sep 16, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787988 ↗
• MalfunctionSep 16, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787979 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520388 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520382 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520326 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520279 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520074 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520073 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519896 ↗
• MalfunctionSep 18, 2025Material Frayed; Material Frayed

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-7250, FIBERWIRE® #0 BRAIDED POLYBLEND SUTURE, BLUE W/TAPERED NEEDLE, WHILST PERFORMING CERCLAGE WITH 0 FIBERWIRE ON AN ACL GRAFT, THE FIBERWIRE OUTER COATING STARTED TO SHRED. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON CONTINUED WITH THE FRAYING SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088554 ↗
• InjuryDec 21, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRAPEZIUM PROCEDURE (B)(6) 2020. DURING THE PROCEDURE THE SURGEON USED ARTHREX, AR-7250 FIBERWIRE SUTURES. SINCE THE PROCEDURE THE INCISION OPENED UP AND THE PATIENT DEVELOPED AN INFECTION WHICH REQUIRED TREATMENT. THE PATIENT HAS BEEN HAVING ONGOING ISSUES SINCE SURGERY WHICH INCLUDE PAIN, ITCHING, REDNESS AND SWELLING. PATIENT HAS HAD ISSUES IN PAST SURGERIES WITH SUTURES/ SOFT PLASTICS. THE CURRENT ISSUES ARE SIMILAR TO THOSE EXPERIENCED IN THE PAST.

  Patient problems: Erythema; Itching Sensation; Pain; Reaction; Swelling; Unspecified Infection; Wound Dehiscence

  MAUDE report 11045098 ↗