Arthrex® AR-3638Recalls & reported problems

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 00888867292123), received between Apr 5, 2018 and Sep 25, 2026 — classified as 40 injuries, 272 malfunctions.

The most frequently reported specific device problem is “Break” (129 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 312 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Dislodged or Dislocated

  On (b)(6) 2026, it was reported by a distributor via an email that for (b)(4) unit of AR-3638, Knotless FiberTak¿ with #2 Suture (5-box), its anchor was pulled out during suture passing step. This was detected during a Bankart Repair procedure on (b)(6) 2026. The procedure was completed successfully by using additional FiberTak. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896657 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856818 ↗
• MalfunctionSep 22, 2026Physical Resistance/Sticking

  On 7 Sep 2026, a distributor reported via email that one unit of AR-3638 Batch 15375020 experienced a device issue. During an MPFL reconstruction procedure performed on (b)(6) 2026, the FiberTak suture became stuck during the suture-passing step. An additional FiberTak device was subsequently used to complete the surgery. AR-3610CTC and AR-3600ND-2 were used for drilling. No device fragments remained in the patient. The procedure was completed successfully using an additional FiberTak device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853041 ↗
• MalfunctionSep 21, 2026Device Dislodged or Dislocated

  On 7th September 2026, it was reported by a Distributor via an Email that for 1 unit of AR-3638, Knotless FiberTak¿ with #2 Suture (5-box), its anchor was pulled out during the suture passing step.This was detected during a Bankart procedure on (b)(6) 2026. The procedure was completed successfully by using additional FiberTak. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842346 ↗
• MalfunctionJun 2, 2026Break; Use of Device Problem

  ON 15TH MAY 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), AFTER ANCHOR DEPLOYMENT, THE SURGEONS NOTICED THAT THERE WERE LOOSE THREADS ON THE BLACK/WHITE SHUTTING SUTURE AND WAS UNABLE TO SHUTTLE THE BLUE REPAIR SUTURE. THE SUTURE EVENTUALLY BROKE OFF LEAVING THE SOFT ANCHOR INSIDE. THIS WAS DETECTED DURING AN INSTABILITY CASE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SUTURETAPE & PUSHLOCK ANCHOR INSTEAD. ADDITIONAL INFORMATION RECEIVED FROM COMPLAINT INITIATOR: THE SOFT ANCHOR WAS LEFT INSIDE PATIENT. THE SURGEONS WERE UNABLE TO RETRIEVE IT BECAUSE IT IS INSIDE PATIENT BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25360318 ↗
• MalfunctionFeb 10, 2026Device Dislodged or Dislocated

  ON 21ST JAN 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-3638 FIBERTAK BATCH 15358672 ENCOUNTERED DIFFICULTY WITH THE SHUTTLE SUTURE SLIDING. DURING THE SURGEON¿S ATTEMPT TO LOCK THE REPAIR SUTURE INTO THE ANCHOR, THE ANCHOR PULLED OUT. THE ISSUE WAS DETECTED INTRAOPERATIVELY ON THE SAME DAY. THE USER PROCEEDED WITH A NEW ANCHOR, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY.

  Patient problems: Insufficient Information

  MAUDE report 24303969 ↗
• MalfunctionDec 29, 2025Material Frayed; Material Frayed

  ON 8TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE SUTURES WERE FRAYED WHILE SHUTTLING THE REPAIR SUTURES. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907032 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 4TH DECEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE FIBERTAK LEADING SUTURE WAS BROKEN DURING SUTURE PASSING STEP. THIS WAS DETECTED DURING USE IN A SLAP REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL FIBERTAK WAS USED. AR-3610CTC & AR-3600ND-2 WERE USED TO DRILL THE HOLE. BONE DENSITY TEST WAS NOT PERFORMED. NO SUTURE FRAGMENT WAS LEFT INTRAARTICULARLY.

  Patient problems: Insufficient Information

  MAUDE report 23888066 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT 2 UNITS OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), WERE PULLED OUT. THE FIRST ANCHOR WAS PULLED OUT DURING SUTURE PASSING PROCESS. THE SECOND ANCHOR WAS PULLED OUT WHILE CHECKING THE ANCHOR WAS DEPLOYED. THIS WAS DETECTED DURING USE IN A SLAP REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON REFUSED TO TRY AGAIN THEN USED THREE COMPETITOR'S PRODUCTS TO COMPLETE THE SURGERY WITH NO FURTHER ISSUE. AR-3610CTC AND AR-3600ND-2 WERE USED TO PREPARE THE SOCKET. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE BONE DENSITY TEST WAS NOT PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 23828657 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 27TH NOVEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT 2 UNITS OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), WERE PULLED OUT. THE FIRST ANCHOR WAS PULLED OUT DURING SUTURE PASSING PROCESS. THE SECOND ANCHOR WAS PULLED OUT WHILE CHECKING THE ANCHOR WAS DEPLOYED. THIS WAS DETECTED DURING USE IN A SLAP REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON REFUSED TO TRY AGAIN THEN USED THREE COMPETITOR'S PRODUCTS TO COMPLETE THE SURGERY WITH NO FURTHER ISSUE. AR-3610CTC AND AR-3600ND-2 WERE USED TO PREPARE THE SOCKET. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE BONE DENSITY TEST WAS NOT PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 23828070 ↗
• MalfunctionDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 13TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF (B)(4), KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE WHOLE ANCHOR WAS PULLED OUT. THE SURGEON HAD DIFFICULTIES IN SHUTTERING THE REPAIR STITCH OF (B)(4) INTO THE ANCHOR SO WHEN HE USED MORE STRENGTH, THE WHOLE ANCHOR WAS PULLED OUT. THIS WAS DETECTED DURING A SHOULDER INSTABILITY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY ANCHORING IT DOWN WITH A PUSHLOCK AS A BILL OUT OPTION. ADDITIONAL INFORMATION RECEIVED ON 17TH NOV 2025: BOTH ANCHORS FACED THE SAME ISSUE OF PULL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707583 ↗
• MalfunctionDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 13TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE WHOLE ANCHOR WAS PULLED OUT. THE SURGEON HAD DIFFICULTIES IN SHUTTERING THE REPAIR STITCH OF AR-3638 INTO THE ANCHOR SO WHEN HE USED MORE STRENGTH, THE WHOLE ANCHOR WAS PULLED OUT. THIS WAS DETECTED DURING A SHOULDER INSTABILITY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY ANCHORING IT DOWN WITH A PUSHLOCK AS A BILL OUT OPTION. ADDITIONAL INFORMATION RECEIVED ON 17TH NOV 2025: BOTH ANCHORS FACED THE SAME ISSUE OF PULL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707289 ↗
• MalfunctionSep 18, 2025Break; Break

  ON 28TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE IMPLANT HOLDER TIP BROKE DURING BEING DEPLOYED. LOOSE PIECES WERE RETRIEVED DURING THE CASE. THIS WAS DETECTED DURING A SHOULDER INSTABILITY REPAIR ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 23084593 ↗
• MalfunctionSep 15, 2025Break; Break

  ON 08/26/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT TWO AR-3638 KNOTLESS FIBERTAK DEVICES MALFUNCTIONED DURING USE. EACH TIME THE SURGEON ATTEMPTED TO PASS THE REPAIR SUTURE BACK TO THE ANCHOR, THE DEVICE BROKE AT THE SAME LOCATION. AS A RESULT, THE TWO ANCHORS WERE NOT USED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 09/03/2025: THIS ISSUE OCCURRED DURING A SHOULDER INSTABILITY PROCEDURE PERFORMED ON (B)(6) 2025. THE CASE WAS COMPLETED USING TWO AR-3638 KNOTLESS FIBERTAK DEVICES FROM THE SAME LOT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 15¿20 MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. NO COMPONENTS BROKE OFF IN THE PATIENT, AND NO ADVERSE EFFECTS WERE REPORTED. NO PHOTOS WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053687 ↗
• MalfunctionSep 15, 2025Break; Break

  ON 08/26/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT TWO AR-3638 KNOTLESS FIBERTAK DEVICES MALFUNCTIONED DURING USE. EACH TIME THE SURGEON ATTEMPTED TO PASS THE REPAIR SUTURE BACK TO THE ANCHOR, THE DEVICE BROKE AT THE SAME LOCATION. AS A RESULT, THE TWO ANCHORS WERE NOT USED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 09/03/2025: THIS ISSUE OCCURRED DURING A SHOULDER INSTABILITY PROCEDURE PERFORMED ON (B)(6) 2025. THE CASE WAS COMPLETED USING TWO AR-3638 KNOTLESS FIBERTAK DEVICES FROM THE SAME LOT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 15¿20 MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. NO COMPONENTS BROKE OFF IN THE PATIENT, AND NO ADVERSE EFFECTS WERE REPORTED. NO PHOTOS WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053557 ↗
• MalfunctionSep 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 21ST AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), 1 UNIT OF AR-3638 WAS PULLED OUT AND 1 UNIT OF AR-3638'S SHUTTING SUTURE WAS FRAYED. THIS WAS DETECTED DURING A SHOULDER BANKART AND REMPLISSAGE REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING ANOTHER IMPLANT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051473 ↗
• MalfunctionSep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 21ST AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), 1 UNIT OF AR-3638 WAS PULLED OUT AND 1 UNIT OF AR-3638'S SHUTTING SUTURE WAS FRAYED. THIS WAS DETECTED DURING A SHOULDER BANKART AND REMPLISSAGE REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING ANOTHER IMPLANT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015053 ↗
• MalfunctionSep 3, 2025Failure to Advance; Failure to Advance

  ON 08/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3638 KNOTLESS FIBERTAK COULD NOT BE USED DURING A PROCEDURE, AS IT FAILED TO PASS THROUGH BOTH THE CURVED AND STRAIGHT DRILL GUIDES. THE CASE WAS COMPLETED UTILIZING A REPLACEMENT AR-3638 KNOTLESS FIBERTAK. THERE WAS NO DELAY IN THE PROCEDURE, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER THE SURGERY. THE EVENT OCCURRED ON (B)(6) 2025, DURING AN UNSPECIFIED PROCEDURE, AS NO PROCEDURAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950924 ↗
• MalfunctionAug 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRACTUS REFIXATION SURGERY BOTH DEVICES PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-2324BCC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884196 ↗
• MalfunctionAug 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRACTUS REFIXATION SURGERY BOTH DEVICES PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-2324BCC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884124 ↗
• MalfunctionAug 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 22ND JULY 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR 2 UNITS OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE KNOTLESS FIBERTAK PASSING SUTURE WAS BROKEN DURING SUTURE PASSING PROCESS CAUSING THE FIXATION SUTURE TO NOT BE ABLE TO PASS THROUGH THE ANCHOR AND COMPLETE THE TENSIONABLE MECHANISM. BOTH ANCHORS HAD THE SAME ISSUE. THIS WAS DETECTED DURING USE IN A SLAP PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW FIBERTAK WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22750291 ↗
• MalfunctionAug 8, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR 2 UNITS OF AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE KNOTLESS FIBERTAK PASSING SUTURE WAS BROKEN DURING SUTURE PASSING PROCESS CAUSING THE FIXATION SUTURE TO NOT BE ABLE TO PASS THROUGH THE ANCHOR AND COMPLETE THE TENSIONABLE MECHANISM. BOTH ANCHORS HAD THE SAME ISSUE. THIS WAS DETECTED DURING USE IN A SLAP PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW FIBERTAK WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22750274 ↗
• MalfunctionAug 7, 2025Break; Break

  ON 18TH JULY 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE KNOTLESS FIBERTAK PASSING SUTURE WAS BROKEN WHILE PASSING PROCESS LED THE REPAIR SUTURE TO BE UNABLE TO PASS THROUGH THE ANCHOR TO COMPLETE THE TENSIONING MECHANISM. THIS WAS DETECTED DURING USE IN A BANKART PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL FIBERTAK WAS USED.

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

  MAUDE report 22736695 ↗
• MalfunctionAug 4, 2025Positioning Failure; Positioning Failure

  ON 17TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), THE REPAIR SUTURE DID NOT SIT PROPERLY IN ANCHOR AFTER SHUTTLING AND HAD TO BE CUT OFF. THIS WAS DETECTED DURING A RIGHT SHOULDER ACROMIOPLASTY CUFF REPAIR BANKART REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING ANOTHER AR-3638. THERE WAS NO PATIENT HARM.

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

  MAUDE report 22707066 ↗
• MalfunctionMay 30, 2025Break; Break

  ON 14TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3638, KNOTLESS FIBERTAK¿ WITH #2 SUTURE (5-BOX), ITS IMPLANT SUTURE BROKE WHEN THE SURGEON PULLED TO REDUCE THE REPAIR SUTURE. THIS WAS DETECTED DURING A SHOULDER INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ONE MORE SUTURE ANCHOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115005 ↗