Arthrex® AR-3632SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867341883), received between May 10, 2021 and Mar 6, 2026 — classified as 1 injury, 36 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 6, 2026Break

  ON 13-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR WITH TWO 1.3 MM SUTURETAPES EXPERIENCED BREAKAGE AT THE TIP OF THE SHAFT AFTER INSERTION INTO THE BONE. THE BROKEN PIECE WAS RETRIEVED WITHOUT COMPLICATION. THE ANCHOR OTHERWISE FUNCTIONED PROPERLY AND WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT SURGICAL DELAY, NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO PATIENT HARM WAS REPORTED. THE EVENT OCCURRED DURING A PROCEDURE PERFORMED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531548 ↗
• MalfunctionJan 12, 2026Material Split, Cut or Torn

  ON 29-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3632SP FIBERTAK ANCHOR SUTURE TORE WHEN IMPLANTING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING ANOTHER ANCHOR. NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043096 ↗
• MalfunctionJan 5, 2026Device Dislodged or Dislocated

  ON 16-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3632SP FIBERTAK® SP SUTURE ANCHORS BACKED OUT. THIS OCCURRED DURING A SHOULDER CASE ON (B)(6) 2025 WHEN AN ISSUE WITH THE STITCHES SLIDING OCCURRED, RESULTING IN THE ANCHORS BACKING OUT. THE CASE CONTINUED USING A HARD SUTURETAK. THE PATIENT HAD A NORMAL BONE QUALITY. THERE WAS NO HARM TO THE PATIENT. THERE WAS A SLIGHT DELAY WHILE GRABBING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958131 ↗
• MalfunctionJan 5, 2026Device Dislodged or Dislocated

  ON 16-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3632SP FIBERTAK® SP SUTURE ANCHORS BACKED OUT. THIS OCCURRED DURING A SHOULDER CASE ON (B)(6) 2025 WHEN AN ISSUE WITH THE STITCHES SLIDING OCCURRED, RESULTING IN THE ANCHORS BACKING OUT. THE CASE CONTINUED USING A HARD SUTURETAK. THE PATIENT HAD A NORMAL BONE QUALITY. THERE WAS NO HARM TO THE PATIENT. THERE WAS A SLIGHT DELAY WHILE GRABBING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958021 ↗
• MalfunctionDec 9, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE COLLATERAL RECONSTRUCTION + ANTERIOR CRUCIATE LIGAMENT SURGERY THE TWO ANCHORS AR-3632SP (LOT: 15436729) AND AR-3630-1 (LOT: 15327535) WHERE INSERTED TO THE TIBIA AND DIDN'T HOLD. ANOTHER ANCHOR WAS INSERTED INSTEAD (AR-3632SP) THAT DID HOLD IN THE BONE AND THE SURGERY ENDED WELL WITH NO DAMGE TO 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 23758009 ↗
• MalfunctionNov 25, 2025Break; Break

  ON 11/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3632SP FIBERTAK® SP SUTURE ANCHORS SUTURES BROKE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025 WHILE IN USE THE SUTURES ALL BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS ABLE TO BE COMPLETED AND THE ANCHORS REMAIN IN THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO HARM ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23643731 ↗
• MalfunctionNov 25, 2025Break; Break

  ON 11/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3632SP FIBERTAK® SP SUTURE ANCHORS SUTURES BROKE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025 WHILE IN USE THE SUTURES ALL BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS ABLE TO BE COMPLETED AND THE ANCHORS REMAIN IN THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO HARM ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23643490 ↗
• MalfunctionAug 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED DURING THE BICEPS TENODESIS SURGERY THAT THE ANCHOR GOT STUCK IN THE DRILL GUIDE CANNULATION. 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 22750503 ↗
• MalfunctionFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 02/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK ANCHORS AND (QTY. 3) OF AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR HAD AN ISSUE WHEN REPAIRING A SUPRASPINATUS TEAR. THE FIRST AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR WAS DEPLOYED SUCCESSFULLY, BUT THE DRILLING WAS PROBLEMATIC FOR THE FIRST ANCHOR. THE 2.6 DRILL WAS CONFIRMED TO BE APPROPRIATELY CHUCKED. THE SECOND SOCKET WAS MORE DIFFICULT, AND SOME METAL SHAVINGS WERE NOTICED AROUND THE DRILL SITE. THE SURGEON HAD TO REVERSE THE DRILL TO REMOVE IT FROM THE DRILL GUIDE, WHICH CAUGHT THE SUTURES FROM THE FIRST ANCHOR AND PULLED IT FROM THE SOCKET. THE SURGEON ASKED FOR TWO MORE AR-3632SP 2.6 FIBERTAK SP SOFT ANCHORS AND ATTEMPTED TO DEPLOY THEM IN EACH SOCKET, BUT BOTH PULLED OUT. THE SURGEON ABANDONED THE FIBERTAKS AND MOVED ON TO 5.5MM CORKSCREWS, WHICH WERE SUCCESSFULLY DEPLOYED IN THE PREVIOUSLY DRILLED SOCKETS. ALL METAL SHAVINGS WERE REMOVED FROM THE SITE, AND THE MEDIAL ROW SUTURES WERE PASSED, TIED, AND BRIDGED TO TWO 5.5MM SWIVELOCKS AS PLANNED. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467241 ↗
• MalfunctionFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 02/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK ANCHORS AND (QTY. 3) OF AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR HAD AN ISSUE WHEN REPAIRING A SUPRASPINATUS TEAR. THE FIRST AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR WAS DEPLOYED SUCCESSFULLY, BUT THE DRILLING WAS PROBLEMATIC FOR THE FIRST ANCHOR. THE 2.6 DRILL WAS CONFIRMED TO BE APPROPRIATELY CHUCKED. THE SECOND SOCKET WAS MORE DIFFICULT, AND SOME METAL SHAVINGS WERE NOTICED AROUND THE DRILL SITE. THE SURGEON HAD TO REVERSE THE DRILL TO REMOVE IT FROM THE DRILL GUIDE, WHICH CAUGHT THE SUTURES FROM THE FIRST ANCHOR AND PULLED IT FROM THE SOCKET. THE SURGEON ASKED FOR TWO MORE AR-3632SP 2.6 FIBERTAK SP SOFT ANCHORS AND ATTEMPTED TO DEPLOY THEM IN EACH SOCKET, BUT BOTH PULLED OUT. THE SURGEON ABANDONED THE FIBERTAKS AND MOVED ON TO 5.5MM CORKSCREWS, WHICH WERE SUCCESSFULLY DEPLOYED IN THE PREVIOUSLY DRILLED SOCKETS. ALL METAL SHAVINGS WERE REMOVED FROM THE SITE, AND THE MEDIAL ROW SUTURES WERE PASSED, TIED, AND BRIDGED TO TWO 5.5MM SWIVELOCKS AS PLANNED. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467185 ↗
• MalfunctionFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 02/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK ANCHORS AND (QTY. 3) OF AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR HAD AN ISSUE WHEN REPAIRING A SUPRASPINATUS TEAR. THE FIRST AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR WAS DEPLOYED SUCCESSFULLY, BUT THE DRILLING WAS PROBLEMATIC FOR THE FIRST ANCHOR. THE 2.6 DRILL WAS CONFIRMED TO BE APPROPRIATELY CHUCKED. THE SECOND SOCKET WAS MORE DIFFICULT, AND SOME METAL SHAVINGS WERE NOTICED AROUND THE DRILL SITE. THE SURGEON HAD TO REVERSE THE DRILL TO REMOVE IT FROM THE DRILL GUIDE, WHICH CAUGHT THE SUTURES FROM THE FIRST ANCHOR AND PULLED IT FROM THE SOCKET. THE SURGEON ASKED FOR TWO MORE AR-3632SP 2.6 FIBERTAK SP SOFT ANCHORS AND ATTEMPTED TO DEPLOY THEM IN EACH SOCKET, BUT BOTH PULLED OUT. THE SURGEON ABANDONED THE FIBERTAKS AND MOVED ON TO 5.5MM CORKSCREWS, WHICH WERE SUCCESSFULLY DEPLOYED IN THE PREVIOUSLY DRILLED SOCKETS. ALL METAL SHAVINGS WERE REMOVED FROM THE SITE, AND THE MEDIAL ROW SUTURES WERE PASSED, TIED, AND BRIDGED TO TWO 5.5MM SWIVELOCKS AS PLANNED. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467137 ↗
• MalfunctionFeb 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR DID NOT COME OF THE FEEDER. 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 21397894 ↗
• MalfunctionOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-3632SP FIBERTAK SP ANCHOR PULLED OUT AFTER IT WAS THREADED. THE CASE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370818 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATERAL LIGAMENT REFIXATION SURGERY THE TIP OF THE DEVICE BROKE OFF DURING INSERTION. THE BROKEN TIP REMAINED INSIDE THE PATIENT. 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 19950826 ↗
• MalfunctionMay 17, 2024Failure to Advance; Failure to Advance

  ON 11/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3632SP FIBERTAK FAILED TO DEPLOY. THIS OCCURRED DURING A ROTATOR CUFF REPAIR WHEN GOING TO DEPLOY THE FIRST IMPLANT WOULD NOT DEPLOY, THE DEVICE WAS UNLOADED AND RELOADED AND WOULD STILL NOT DEPLOY. THE CASE WAS COMPLETED USING A 5/5 CORKSCREW WITH 4 NEEDLES. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340156 ↗
• MalfunctionMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632SP SELF-PUNCHING FIBERTAK ANCHOR PULLED OUT WHEN SURGEON SLOWLY PULLED ON THE SUTURES TO SET THE ANCHOR. THIS WAS DISCOVERED DURING A REMPLISSAGE PROCEDURE ON (B)(6) 2022. A DIFFERENT ANCHOR WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19288252 ↗
• MalfunctionMay 10, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED ON 12/09/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3632SP FIBERTAK IMPLANT PULLED OUT AFTER INSERTION. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285795 ↗
• MalfunctionMay 9, 2024Failure to Advance; Failure to Advance

  ON 10/3/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3632SP FIBERTAK SP SUTURE ANCHOR WOULD NOT SEAT IN THE PATIENT'S BONE. SURGEON USED ANOTHER FIBERTAK FROM A DIFFERENT LOT NUMBER AND A CORKSCREW TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19279621 ↗
• MalfunctionMay 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/25/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3632SP FIBERTAK ANCHOR PULLED OUT OF INSERTION SITE . THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258788 ↗
• MalfunctionFeb 6, 2024Break; Break

  ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-3632SP FIBERTAK® SP SUTURE ANCHOR BROKE. THIS OCCURRED ON (B)(6)2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18650586 ↗
• MalfunctionJan 30, 2024Failure to Capture; Failure to Capture

  ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-3632SP FIBERTAK® SP SUTURE ANCHORS MOUTH DID NOT CAPTURE THE MENISCUS. THIS OCCURRED ON (B)(6)2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18608781 ↗
• MalfunctionJan 5, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 4/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3632SP SELF-PUNCHING 2.6 FIBERTAK INSERTER SHAFT BENT DURING INSERTION BUT DID NOT BREAK. SURGEON USED ANOTHER AR-3632SP SELF-PUNCHING 2.6 FIBERTAK TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN RCR ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450419 ↗
• MalfunctionDec 28, 2023Break; Break

  ON 11/15/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-3632SP SELF-PUNCHING FIBERTAK ANCHOR SUTURE RIPPED FROM ANCHOR BODY AFTER INSERTION. ANCHOR WAS REMOVED FROM PATIENT AND A NEW ANCHOR WAS INSERTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 11/15/2021: SURGEON WAS PERFORMING A BICEP TENODESIS WHEN FIBERTAK BROKE INSIDE THE PATIENT. ALL BROKEN FRAGMENTS WERE RETRIEVED AND PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411090 ↗
• MalfunctionDec 28, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 11/15/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632SP SELF-PUNCHING FIBERTAK BENT TO ONE SIDE, NEAR THE FLAT TOP OF THE INSERTER. SURGEON REMOVED ANCHOR, STRAIGHTENED THE INSERTER, AND WITH A MALLET REATTEMPTED INSERTION OF THE ANCHOR BUT IT BENT AGAIN. CONCERNED THAT THE METAL FIBERTAK INSERTER MAY BREAK INSIDE HE PATIENT'S SHOULDER, SURGEON REMOVED THE ANCHOR AND USED A NEW FIBERTAK TO COMPLETE THE CASE SUCCESSFULLY. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411030 ↗
• MalfunctionDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/22/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3632SP FIBERTAK SP PULLED OUT OR BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18376098 ↗