Arthrex® AR-6060-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867204638), received between Feb 3, 2017 and Mar 2, 2026 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break; Material Frayed

  ON 09-FEB -2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6060-90 SUTURESNARE WIRE WAS FRAYED AND BROKE SHORTLY AFTER OPENING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE PROCEDURE WAS COMPLETED AFTER USING A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483551 ↗
• MalfunctionApr 29, 2025Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A ROTATOR CUFF RECONSTRUCTION SURGERY THE SURGEON FOUND THAT THE FLEXIBLE TIP WAS ALREADY PARTIALLY OUTSIDE IN THE PACKAGING. THE SURGEON USED THE DEVICES ANYWAY. THE FLEXIBLE TIP COULD NO LONGER BE RETRACTED INWARDS AND BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER 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 21928110 ↗
• MalfunctionApr 29, 2025Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A ROTATOR CUFF RECONSTRUCTION SURGERY THE SURGEON FOUND THAT THE FLEXIBLE TIP WAS ALREADY PARTIALLY OUTSIDE. THE FLEXIBLE TIP COULD NO LONGER BE RETRACTED INWARDS AND BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER 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 21928106 ↗
• MalfunctionApr 29, 2025Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A ROTATOR CUFF RECONSTRUCTION SURGERY THE SURGEON FOUND THAT THE FLEXIBLE TIP WAS ALREADY PARTIALLY OUTSIDE IN THE PACKAGING. THE SURGEON USED THE DEVICES ANYWAY. THE FLEXIBLE TIP COULD NO LONGER BE RETRACTED INWARDS AND BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER 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 21928101 ↗
• MalfunctionApr 28, 2025Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A ROTATOR CUFF RECONSTRUCTION SURGERY IN 2024, THE SURGEON FOUND THAT THE FLEXIBLE TIP WAS ALREADY PARTIALLY OUTSIDE IN THE PACKAGING. THE SURGEON USED THE DEVICES ANYWAY. THE FLEXIBLE TIP COULD NO LONGER BE RETRACTED INWARDS AND BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918288 ↗
• MalfunctionFeb 10, 2025Defective Device; Defective Device

  ON 01/27/2025, IT WAS REPORTED BY A ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6060-90 SUTURESNARE TIP WAS DEFORMED AND WIRE COULD NOT BE RETRACTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT HARM. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF OF COMPETING COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344330 ↗
• MalfunctionNov 26, 2024Break; Break

  ON 10/31/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06698648 THAT AN AR-6060-90 SUTURESNARE WAS DIFFICULT TO PUSH OUT FROM THE BEGINNING, AND AFTER INSERTING AND MOVING IT THREE TIMES, THE TIP OF THE WIRE BROKE. THE SURGEON TRIED TO RETRIEVE THE BROKEN TIP, BUT UNABLE TO FIND IT, SO HE GAVE UP AND LEFT IT INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A CASE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20782459 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY WITH CALCIUM REMOVAL AN ACT-JOINT EXTENSION, WHILE ATTEMPTING TO RETRIEVE SUTURE THE WIRE TIP OF THE FIRST AR-6060-90 BROKE OFF, THE SECOND AR-6060-90 TIP BENT INTO AN OPEN POSITION UPON THE FIRST USE OF SUTURE RETRIEVAL, WAS NOT OPERABLE THEREAFTER. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH PART NUMBER AR-4068-90. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625476 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY WITH CALCIUM REMOVAL AN ACT-JOINT EXTENSION, WHILE ATTEMPTING TO RETRIEVE SUTURE THE WIRE TIP OF THE FIRST AR-6060-90 BROKE OFF, THE SECOND AR-6060-90 TIP BENT INTO AN OPEN POSITION UPON THE FIRST USE OF SUTURE RETRIEVAL, WAS NOT OPERABLE THEREAFTER. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH PART NUMBER AR-4068-90. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624402 ↗
• MalfunctionApr 23, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AFTER PIERCING THE SUPRASPINATUS, THE AR-6060-90 WIRE DID NOT COME OUT. NO ADVERSE EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165609 ↗
• MalfunctionMar 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR THE TRIGGER ON THE PASSER GOT STUCK, SURGEON COMPLAINED AND OPENED A NEW ONE. 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 18951371 ↗
• MalfunctionFeb 13, 2023Break

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6060-90 SUTURE SNARE BROKE DURING A CASE. THE SURGEON WAS ATTEMPTING TO FIX A PARTIAL SUBSCAPULARIS REPAIR. HE PENETRATED THE SUB-SCAP WITH THE SUTURE-SNARE AND USED THE DEPLOYING "SNARE" TO CAPTURE A FREE END OF A AR-7237-7 FIBER-TAPE. HE MOVED THE THUMB POSITION TO THE "BACK POSITION" TO GRASP THE SUTURE. AS HE BEGAN TO REMOVE THE SUTURE-SNARE DEVICE WITH THE FIBER-TAPE END SECURED IN THE "SNARE", THE "SNARE" BROKE OFF IN THE GLENOHUMERAL JOINT. THE DEVICE WAS REMOVED AND DISCARDED. THE BROKEN PIECE WAS REMOVED FROM THE JOINT WITH AN ARTHROSCOPIC GRASPER. THE CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361774 ↗
• MalfunctionMar 22, 2021Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE DEVICE DIDN`T DEPLOY WITHOUT USING GREAT FORCE DURING A ROTATOR CUFF REPAIR SURGERY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO PIECE OF THE DEVICE BROKE OFF DURING THE PROCEDURE. THE SURGEON SWITCHED TO A DIFFERENT SURGICAL TECHNIQUE USING A 45 DEG L LASSO. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-6068-45L). IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE 05-MAR-2021: IT WAS FURTHER REPORTED THAT THE SURGERY TOOK 30 MINUTES LONGER BECAUSE SUTURES HAD TO BE SHUTTLED. NO EXTRA INCISIONS WERE REQUIRED TO BE MADE. UPDATE 08-MAR-2021: THE DURATION OF THE OPERATION WAS IN THE REGION OF 1HR 30 - 1HR 40MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11540272 ↗
• InjuryMar 15, 2018Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, WHEN THE SURGEON WAS RETRIEVING A SUTURE, THE METAL TIP OF THE SUTURESNARE BROKE OFF INTO THE PATIENT'S SOFT TISSUE AND WAS UNABLE TO BE RECOVERED. A SECOND SUTURESNARE WAS OPENED AND USED TO COMPLETE THE CASE AND THE TIP OF THIS ONE BROKE OF AS WELL. THE TIP OF THE SECOND SUTURE SNARE WAS RETRIEVED AND THE CASE WAS COMPLETED. PATIENT IS A MALE, 65. FOLLOW-UP INVESTIGATION: AN X-RAY WAS NOT TAKEN. THE SURGEON LOOKED FOR THE FIRST TIP BUT DETERMINED THAT IT WAS IN THE SOFT TISSUE AND COULD NOT BE RETRIEVED. THE SECOND TIP WAS FOUND AND REMOVED. THERE WERE NO UNPLANNED INCISIONS. THE CASE WAS COMPLETED BY PASSING THE SUTURES WITH A BIRDBEAK TO COMPLETE THE PASTA REPAIR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7341112 ↗
• InjuryMay 17, 2017Break; Physical Resistance; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A 90° SUTURE SNARE. HE CAUGHT A SUTURE WITH THE SNARE AND AS HE PULLED, HE FELT RESISTANCE. HE CONTINUED TO PULL AND THE TIP OF THE WIRE BROKE OFF INTO THE PATIENT'S JOINT. THE SURGEON ATTEMPTED TO RETRIEVE THE TIP BUT WAS UNSUCCESSFUL AS HE WAS UNABLE TO LOCATE THE TIP. THE FRAGMENT REMAINED IN PATIENT BODY. THE SURGEON TOOK A POST-OP X-RAY HOWEVER, THE TIP COULD NOT BE SEEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6571648 ↗
• InjuryApr 26, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A 90° SUTURE SNARE. THE SURGEON CAUGHT SUTURE WITH THE SUTURE SNARE AND PULLED STRONGLY. THE TIP OF THE WIRE BROKE OFF INTO THE PATIENT AND WAS NOT ABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6522508 ↗
• InjuryMar 10, 2017Material Fragmentation

  IT WAS REPORTED THAT DURING A LEFT ROTATOR CUFF REPAIR PROCEDURE, WHILE THE SURGEON WAS PASSING THE SUTURE, THE TIP OF THE 90° STRAIGHT SUTURESNARE, AR-6060-90, BROKE OFF. THE TIP WAS RETRIEVED WITH GRASPERS AND A SECOND 90° STRAIGHT SUTURE SNARE OF THE SAME LOT WAS OPENED AND AGAIN, AS THE SURGEON WAS ATTEMPTING TO PASS THE SUTURE, THE TIP OF THE DEVICE BROKE-OFF INTO THE PATIENT. THIS TIME, THE SURGEON WAS UNABLE TO LOCATE THE TIP AND AN X-RAY WAS BROUGHT IN TO CONFIRM THAT THE TIP WAS STILL INSIDE OF THE PATIENT. AFTER AN HOUR AND A HALF OF ATTEMPTING TO RETRIEVE THE BROKEN TIP THE SURGEON COMPLETED THE CASE WITH THE TIP STILL INSIDE THE PATIENT. INCIDENT RESULTED IN A 1.5 HOUR DELAY IN CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6394906 ↗
• InjuryFeb 3, 2017Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT DURING A PASTA PROCEDURE, THE TIP OF THE AR-6060-90, 90° STRAIGHT SUTURE SNARE, BROKE WHILE THE SURGEON WAS PASSING THE SUTURE FOR THE 4TH TIME. THE BROKEN TIP WAS NOT LOCATED IN OR OUT OF THE PATIENT. THE SURGEON COMPLETED THE CASE USING A BIRDBEAK DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6300523 ↗