Arthrex® AR-3641-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867290952), received between Jul 5, 2022 and Mar 3, 2026 — classified as 3 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE IMPLANT DESTABILIZED DESPITE A PROPERLY PERFORMED IMPLANTATION PROCEDURE. 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 24496742 ↗
• MalfunctionMar 3, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE ANCHOR DID NOT DEPLOY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE ANCHOR REMAINED INSIDE THE PATIENT. THE DEVICE WAS SECURED WITH THE LIGAMENT STAPLE AR-1006. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24495690 ↗
• MalfunctionFeb 23, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE IMPLANT DID NOT PROPERLY ANCHOR IN THE PREPARED HOLE. 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 24414216 ↗
• MalfunctionJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE ANCHOR BACKED OUT WHILE BEING SCREWED INTO THE PREDRILLED CHANNEL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037479 ↗
• MalfunctionJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE DIDN'T WORK. 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. UPDATE 30-DEC-2025: IT WAS FURTHER REPORTED THAT THE ANCHOR DID NOT DEPLOY CORRECTLY AND THE DEVICE PULLED OUT OF THE PREPARED BONE CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011139 ↗
• MalfunctionDec 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE SUTURE TORE WHILE INSERTION INTO THE BONE. 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 23935447 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE ANCHOR BROKE. THE BROKEN PIECES 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 23924117 ↗
• MalfunctionDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR DURING TIGHTENING, THE IMPLANT CAME OUT OF THE BONE FROM THE IMPLANTATION SITE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. THE SURGEON USED A SCREW FOR THE FIXATION. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757011 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE LIGAMENTOPLASTY WHEN PLACING THE ANCHOR, THE ANCHOR IMPLANTATION DEVICE BROKE AND A FRAGMENT REMAINED IN THE BONE. IT WAS IMPOSSIBLE TO EXTRACT IT. 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: Foreign Body In Patient

  MAUDE report 23619615 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LEMAIR SURGERY THE SUTURE OF THE ANCHOR TORE. 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 23300173 ↗
• InjuryJul 14, 2025Break; Break

  ON 18TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-3641-1, 2.6 MM KNOTLESS FIBERTAK¿ ANCHOR, THE TIP OF THE SHAFT BROKE DURING THE PROCEDURE. THIS WAS DETECTED AFTER AN UNSPECIFIC PROCEDURE ON (B)(6) 2025. THE BROKEN TIP WAS NOT IDENTIFIED AT THE TIME OF THE SURGERY. THE BROKEN TIP WAS IDENTIFIED ON XRAY POST OPERATION. THE PATIENT WAS TAKEN BACK TO REMOVE THE TIP OF THE INSERTER SEVERAL HOURS LATER. THE TIP WAS REMOVED AND ACCOUNTED FOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 22500495 ↗
• MalfunctionMar 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SUTURE OF AN AR-3641-1 HAS TORN. 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 21643491 ↗
• MalfunctionNov 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MODIFIED LEMAIRE SURGERY THE SUTURE TORE DURING TIGHTENING. 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 20587065 ↗
• MalfunctionSep 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE SUTURE OF THE DEVICE TORE WHILE TIGHTENING THE LOOP. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20303013 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIY SURGERY THE SUTURE TORE WHILE TIGHTENING THE LOOP. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20255804 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIY SURGERY THE SUTURE TORE WHILE TIGHTENING THE LOOP. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20255666 ↗
• MalfunctionSep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR PULLED OUT AND DIDN'T HOLD IN THE BONE. 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 20248659 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY SURGERY AT THE TIME OF IMPACT THE DEVICE BROKE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE AVOE 02-AUG-2024. IT WAS CONFIRMED THAT THE SHEATH OF THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039588 ↗
• MalfunctionAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE IMPLANT SLIPPED OUT OF THE PREPARED CHANNEL. 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 19948366 ↗
• MalfunctionJul 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE IMPLANT PULLED OUT OF THE PREPARED CHANNEL. 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 19785243 ↗
• MalfunctionJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE IMPLANT PULLED OUT OF THE PREPARED CHANNEL. 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 19759692 ↗
• MalfunctionJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE IMPLANT PULLED OUT OF THE PREPARED CHANNEL. 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 19759603 ↗
• InjuryJul 12, 2024Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPARENTLY A FAILURE WITH THE REPORTED DEVICES HAS OCCURRED DURING A SURGERY. HOWEVER IT WAS REPORTED THAT THE SURGEON HAD TO CHANGE THE PROCEDURE TO BE ABLE TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733754 ↗
• InjuryJul 9, 2024Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated

  ***UPDATE DW 18-JUL-2024: FURTHER INFORMATION WAS PROVIDED THAT THE REQUESTED TRANSLATION WAS FORWARDED AND REGISTERED IN (B)(4). THE FOLLOWING TRANSLATION WAS MADE AVAILABLE. IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE IMPLANT PULLED OUT OF THE PREPARED CHANNEL. 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 19701528 ↗
• MalfunctionJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE IMPLANT PULLED OUT DURING TIGHTENING AND DID NOT HOLD IN THE BONE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19592984 ↗