Arthrex® AR-2324BCT-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00888867251236), received between Jun 21, 2018 and Sep 9, 2025 — classified as 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON 8/19/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK METAL SHAFT BENT UPON IMPACTING THE EYELET. THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08/27/2025: DURING THE PROCEDURE, THE EYELET OF THE AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK BROKE OFF INSIDE THE PATIENT. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK AND THE SAME TECHNIQUE. THE PROCEDURE EXPERIENCED A BRIEF TWO-MINUTE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003458 ↗
• MalfunctionSep 16, 2024Break; Break

  ON 9/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING INSERTION. THE SURGEON DRILLED WITH THE APPROPRIATE SIZE DRILL AND THEN TAPPED WITH THE APPROPRIATE SIZE TAP. WHEN THE SWIVELOCK WAS TURNED INTO THE TIBIA, THE ANCHOR BODY BROKE IN HALF, AND THE EYELET BROKE AS WELL. ONLY THE INTERNALBRACE SUTURE REMAINED IN THE EYELET. THE CASE WAS COMPLETED USING ANOTHER AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK. THE CASE WAS NOT DELAYED, AND THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226756 ↗
• MalfunctionJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RETENTION SUTURES IN THE AR-2324BCT-2 ANCHOR COMPLETELY PULLED OUT WHEN THE SURGEON REMOVED THE INSERTER. SEE SOURCE DATA AND IMAGE ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 19558895 ↗
• MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE #2 TIGERTAIL RENTENTION SUTURES WERE NOT SLIDING THROUGH THE ANCHOR AND THEREFORE UNABLE TO BE PASSES. THESE SUTURES HAD TO BE CUT OUT FROM THE TOP OF THE ANCHOR AND A NEW AR-2324BCT-2 WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19491322 ↗
• MalfunctionApr 24, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2324BCT-2, DOUBLE LOADED SWIVELOCK BENT THE ENDS OF THE ANCHOR. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION 02/02/2022 ON 02/02/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2324BCT-2, DOUBLE LOADED SWIVELOCK BENT THE ENDS OF THE ANCHOR. NOTHING BROKE OFF. THIS WAS DISCOVERED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED USING A NEW AR-2324BCT-2.

  Patient problems: Insufficient Information

  MAUDE report 19171252 ↗
• MalfunctionApr 2, 2024Break; Break

  ON 3/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK C, DOUBLE-LOADED, HAD AN ISSUE DURING THE CASE WHEN BEING USED TO ANCHOR DOWN THE INTERNAL BRACE SUTURE INTO THE TIBIA. THE SURGEON DRILLED WITH THE APPROPRIATE 4.75 DRILL FOR THE SWIVELOCK. HE THEN USED A 5.5MM TAP TO TAP THE DRILL HOLE. BEFORE DUNKING THE SUTURE WITH THE ANCHOR, HE MEASURED OUT THE SUTURE TO ENSURE HE WAS NOT OVER-TENSIONING THEM. WHEN HE WENT TO PLACE THE FIRST SWIVELOCK, HE STARTED TURNING THE ANCHOR IN, AND RIGHT AWAY, IT WOULD NOT GO IN. HE THEN PULLED THE ANCHOR BACK, AND THEY NOTICED THAT THE LEADING THREADS ON THE ANCHOR WERE COMPRESSED AND DID NOT FUNCTION APPROPRIATELY (ATTACHED IS AN IMAGE OF THE FIRST ANCHOR). THEY THEN ATTEMPTED A SECOND SWIVELOCK, AND WHEN HE WAS SCREWING IN THE NEXT ANCHOR, IT GOT ABOUT HALFWAY AND THEN BROKE. HE CUT THE ANCHOR FLUSH TO THE BONE AND LEFT THE REMAINING ANCHOR AS IT SEEMED TO HOLD THE STITCH. THERE WAS A CASE DELAY OF FIVE MINUTES. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON 3/14/2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 19019967 ↗
• MalfunctionApr 2, 2024Failure to Advance; Failure to Advance

  ON 3/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK C, DOUBLE-LOADED, HAD AN ISSUE DURING THE CASE WHEN BEING USED TO ANCHOR DOWN THE INTERNAL BRACE SUTURE INTO THE TIBIA. THE SURGEON DRILLED WITH THE APPROPRIATE 4.75 DRILL FOR THE SWIVELOCK. HE THEN USED A 5.5MM TAP TO TAP THE DRILL HOLE. BEFORE DUNKING THE SUTURE WITH THE ANCHOR, HE MEASURED OUT THE SUTURE TO ENSURE HE WAS NOT OVER-TENSIONING THEM. WHEN HE WENT TO PLACE THE FIRST SWIVELOCK, HE STARTED TURNING THE ANCHOR IN, AND RIGHT AWAY, IT WOULD NOT GO IN. HE THEN PULLED THE ANCHOR BACK, AND THEY NOTICED THAT THE LEADING THREADS ON THE ANCHOR WERE COMPRESSED AND DID NOT FUNCTION APPROPRIATELY (ATTACHED IS AN IMAGE OF THE FIRST ANCHOR). THEY THEN ATTEMPTED A SECOND SWIVELOCK, AND WHEN HE WAS SCREWING IN THE NEXT ANCHOR, IT GOT ABOUT HALFWAY AND THEN BROKE. HE CUT THE ANCHOR FLUSH TO THE BONE AND LEFT THE REMAINING ANCHOR AS IT SEEMED TO HOLD THE STITCH. THERE WAS A CASE DELAY OF FIVE MINUTES. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON 3/14/2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019854 ↗
• MalfunctionFeb 28, 2024Break; Break

  ON 2/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK ANCHORS BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE RETRIEVED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024 AND IT WAS COMPLETED USING ANOTHER AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK FROM A DIFFERENT LOT NUMBER. THE CASE WAS DELAYED ABOUT FIVE TO TEN MINUTES; HOWEVER, THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18804235 ↗
• MalfunctionFeb 28, 2024Break; Break

  ON 2/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK ANCHORS BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE RETRIEVED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024 AND IT WAS COMPLETED USING ANOTHER AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK FROM A DIFFERENT LOT NUMBER. THE CASE WAS DELAYED ABOUT FIVE TO TEN MINUTES; HOWEVER, THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18804207 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON 12/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1593-BC BIOCOMPOSITE SWIVELOCK IMPLANT SYSTEM AND (2) AR-2324 BCT-2 BIOCOMPOSITE SWIVELOCK WERE USED DURING A PROXIMAL HAMSTRING REPAIR PROCEDURE. THE PATIENT HAS BEEN EXPERIENCING CYSTIC FORMATION, DRAINAGE FROM THE ANCHOR SITE, AND PAIN. THE PATIENT REQUIRED ADDITIONAL WASHOUT OF THE INFECTED AREA. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Abscess

  MAUDE report 18496142 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 12/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1593-BC BIOCOMPOSITE SWIVELOCK IMPLANT SYSTEM AND (2) AR-2324 BCT-2 BIOCOMPOSITE SWIVELOCK WERE USED DURING A PROXIMAL HAMSTRING REPAIR PROCEDURE. THE PATIENT HAS BEEN EXPERIENCING CYSTIC FORMATION, DRAINAGE FROM THE ANCHOR SITE, AND PAIN. THE PATIENT REQUIRED ADDITIONAL WASHOUT OF THE INFECTED AREA. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Abscess

  MAUDE report 18496135 ↗
• MalfunctionDec 26, 2023Break; Break

  ON 11/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK EYELET BROKE UPON INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK FROM A DIFFERENT LOT NUMBER. ADDITIONAL INFORMATION RECEIVED ON 12/1/2023: THIS WAS DISCOVERED DURING AN ATFL AND CFL INTERNALBRACE PROCEDURE. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394759 ↗
• InjuryNov 7, 2022Break

  ON 10/18/2022, IT WAS REPORTED BY MEDWATCH VIA EMAIL THAT AN AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK ANCHOR WAS IMPLANTED IN A PATIENT IN THE YEAR 2020. THE PATIENT BENT OVER AND A POP IN THE SHOULDER WAS HEARD FOLLOWED BY A SHOOTING PAIN DOWN THE ARM. PATIENT COULD NOT MOVE THE ARM OR FEEL TWO FINGERS FOR FIVE WEEKS. AN MRI WAS PERFORMED TWO WEEK LATER, WHICH CONFIRMED THAT THE ANCHOR HAD SHATTERED IN THE SHOULDER. THE ANCHOR HAD BROKEN INTO FOUR PIECES AND WERE REMOVED DURING A REVISION SURGERY ON (B)(6) 2021. FOR OVER A YEAR, AFTER REVISION SURGERY, PATIENT STILL EXPERIENCES PAIN IN THE SHOULDER AND STILL CANNOT FEEL TWO FINGERS. PATIENT WAS REFERRED TO SEE A HAND DOCTOR FOR THE NUMBNESS IN THE FINGERS AND IT WAS DETERMINED THAT THE BROKEN ANCHOR HAD CAUSED BRACHIAL PLEXUS INJURY, WHICH DEVELOPED INTO THORACIC OUTLET SYNDROME. A THORACIC SURGEON CONFIRMED THE DIAGNOSIS. PATIENT IS BACK TO PHYSICAL THERAPY AND IS FACING ANOTHER SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Numbness; Pain

  MAUDE report 15743259 ↗
• MalfunctionOct 17, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK EYELET BROKE WHILE THE SURGEON WAS INSERTING THE ANCHOR. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022. SURGEON REMOVED ALL THE BROKEN PIECES AND WAS ABLE TO COMPLETE THE CASE WITH ANOTHER AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614989 ↗
• MalfunctionMay 31, 2022Break; Material Deformation

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCT-2 BIO-COMPOSITE SWIVELOCK ANCHOR BECAME DEFORMED UPON INSERTION. SURGEON OPENED A NEW ANCHOR AND COMPLETED THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN RCR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THE ANCHOR DEFORMED AND ENDED UP BREAKING INSIDE THE PATIENT, ALL FRAGMENTS WERE RETRIEVED. SURGEON COMPLETED CASE USING ANOTHER AR-2324BCT-2 BIO-COMPOSITE SWIVELOCK FROM LOT NUMBER 14180386. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547974 ↗
• MalfunctionMar 14, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2324BCT-2 BIO-COMPOSITE SWIVELOCK® SUTURE ANCHOR HAD A MALFUNCTION. THE ANCHOR WAS BEING INSERTED DURING A PROCEDURE ON (B)(6) 2022 IN A SHOULDER AND WHEN THE SURGEON INSERTED IT AND WAS PULLING IT BACK, IT BROKE AND A PIECE FLIPPED OFF IT, IT WAS NOT SEEN WHEN THE SCOPE WAS USED TO CHECK. THE ANCHOR WAS REMOVED AND A NEW ONE WAS PUT IN WITHOUT INCIDENT, NO OBVIOUS HARM AND NO UNEXPECTED OR PROLONGED CARE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757848 ↗
• MalfunctionFeb 28, 2022Break; Unraveled Material; Positioning Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8990ST FIBERTAK WAS INSERTED INTO THE PATIENT BUT THE ANCHOR DID NOT SEAT. SURGEON OPENED ANOTHER FIBERTAK AND IT WORKED PERFECTLY. DURING THE SAME PROCEDURE, AN AR-2324BCT-2 4.75 SWIVELOCK ANCHOR BROKE OFF INTO THE PATIENT'S BONE WHEN BEING INSERTER. SURGEON REMOVED ALL BROKEN FRAGMENTS AND OPENED ANOTHER 4.75 SWIVELOCK, HOWEVER, AFTER REMOVING THE INSERTER, THE ANCHOR PULLED OUT OF IMPLANTATION SITE. A THIRD SWIVELOCK WAS OPENED TO COMPLETE THAT PORTION OF THE PROCEDURE. THEN, WHILE USING AN AR-8979P DX SWIVELOCK, IT UNRAVELED FROM THE INSERTER AND PULLED OUT. SURGEON WAS ABLE TO USE ANOTHER SWIVELOCK TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2022. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13621049 ↗
• MalfunctionFeb 28, 2022Break; Unraveled Material

  ON 2/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8990ST FIBERTAK WAS INSERTED INTO THE PATIENT BUT THE ANCHOR DID NOT SEAT. SURGEON OPENED ANOTHER FIBERTAK AND IT WORKED PERFECTLY. DURING THE SAME PROCEDURE, AN AR-2324BCT-2 4.75 SWIVELOCK ANCHOR BROKE OFF INTO THE PATIENT'S BONE WHEN BEING INSERTER. SURGEON REMOVED ALL BROKEN FRAGMENTS AND OPENED ANOTHER 4.75 SWIVELOCK, HOWEVER, AFTER REMOVING THE INSERTER, THE ANCHOR PULLED OUT OF IMPLANTATION SITE. A THIRD SWIVELOCK WAS OPENED TO COMPLETE THAT PORTION OF THE PROCEDURE. THEN, WHILE USING AN AR-8979P DX SWIVELOCK, IT UNRAVELED FROM THE INSERTER AND PULLED OUT. SURGEON WAS ABLE TO USE ANOTHER SWIVELOCK TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2022. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13620994 ↗
• MalfunctionFeb 14, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK SUTURE ANCHORS BROKE ABOUT A THIRD OF THE WAY DOWN. THIS OCCURRED DURING A QUAD TENDON REPAIR ON (B)(6) 2022. ALL RESIDUAL ANCHOR AND EYELET WERE REMOVED FROM THE PATIENT. THE SPADE TIP DRILL WAS REINTRODUCED AND DRILL AGAIN FOLLOWED BY A CIRCLE MOTION WITH DRILL TO WIDEN THE APERTURE. THE DARK GREEN TAP WAS USED AGAIN TAPPING ALL THE WAY AND LETTING REST IN BONE FOR 20 SECONDS. A NEW AR-2324BCT-2 WAS OPENED TO COMPLETE THE CASE WITH NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13525932 ↗
• MalfunctionNov 22, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY MULTIPLE WIRES BROKE AS SOON AS THE SURGEON REMOVED THE IMPLANT GUIDE FROM THE SWIVELOCK. THE WIRES BROKE AT THE JUNCTION OF THE WIRE COLOR CHANGE. THE ANCHORS REMAINED INSIDE THE PATIENT WITHOUT BEING USED FOR REPAIR. OTHER TUNNELS HAD TO BE DRILLED AND THE SURGERY WAS FINISHED WITH A DIFFERENT APPROACH AND A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 12854648 ↗
• InjuryNov 22, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY MULTIPLE WIRES BROKE AS SOON AS THE SURGEON REMOVED THE IMPLANT GUIDE FROM THE SWIVELOCK. THE WIRES BROKE AT THE JUNCTION OF THE WIRE COLOR CHANGE. THE ANCHORS REMAINED INSIDE THE PATIENT WITHOUT BEING USED FOR REPAIR. OTHER TUNNELS HAD TO BE DRILLED AND THE SURGERY WAS FINISHED WITH A DIFFERENT APPROACH AND A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 12853829 ↗
• MalfunctionAug 10, 2021Break

  IT WAS REPORTED DURING A SHOULDER REPAIR PROCEDURE, THE SURGEON INSERTED THE AR-2324BCT-2, DOUBLE LOADED SWIVEL LOCK, AS THE SURGEON GENTLY TIGHTEN DOWN THE SUTURE THE SUTURE BROKE WITHIN THE ANCHOR. THE ANCHOR WAS SEATED AND SECURED, THE BROKE SUTURES WERE REMOVED. THE SURGEON INSERTED A SECOND AR-2324BCT-2, DOUBLE LOADED SWIVEL LOCK, THE ANCHOR WAS SEATED SECURED, AS THE SURGEON LIGHTLY PULLED THE SUTURE COILED UP. THE BROKEN SUTURE WAS REMOVED AND THE CASE WAS COMPLETED BY CREATING A NEW TUNNEL AND USING A NEW AR-1927PSF-3 TO COMPLETE THE CASE. NO PATIENT HARM REPORTED. THE CASE WAS PROLONGED A LITTLE LONGER THEN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300350 ↗
• MalfunctionJun 21, 2021Break; Material Separation

  IT WAS REPORTED DURING A SHOULDER REPAIR PROCEDURE, THE SURGEON INSERTED THE AR-2324BCT-2, DOUBLE LOADED SWIVEL LOCK, AS THE SURGEON GENTLY TIGHTEN DOWN THE SUTURE THE SUTURE SEPARATED AND BROKE. THE ANCHOR WAS SEATED AND SECURED, THE BROKE SUTURES WERE REMOVED. THE SURGEON INSERTED A SECOND AR-2324BCT-2, DOUBLE LOADED SWIVEL LOCK, THE ANCHOR WAS SEATED SECURED, AS THE SURGEON LIGHTLY PULLED THE SUTURE COILED UP. THE BROKEN SUTURE WAS REMOVED AND THE CASE WAS COMPLETED USING 3 ADDITIONAL AR-2324BCT-2'S.

  Patient problems: Insufficient Information

  MAUDE report 12032408 ↗
• MalfunctionJun 15, 2021Material Split, Cut or Torn

  IT WAS REPORTED THAT A DOUBLE LOADED SWIVELOCK ARRIVED WITH SHREDDED SUTURES, APPEARING LIKE THEY HAD DE-THREADED RIGHT WHERE THE TIGERTAIL PORTION OF THE SUTURE MET THE SOLID COLORED PORTION OF THE SUTURE. THIS WAS NOTICED WHEN TRYING TO SLIDE THE SUTURES BACK AND FORTH AFTER IMPLANTATION DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED BY LEAVING THE ANCHOR IMPLANTED, AND USED A NEW ONE BY PUNCHING IN THE SAME HOLE AND WAS ABLE TO REMOVE SMALL PIECES AND IMPLANT ANOTHER ANCHOR IN THE SAME LOCATION.

  Patient problems: Insufficient Information

  MAUDE report 11998688 ↗
• MalfunctionJun 7, 2021Difficult to Insert; Material Separation; Output Problem

  IT WAS REPORTED DURING A SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR, THE TIP RETENTION SUTURES ON A QUANTITY TWO AR-2324BCT-2 RIPPED THROUGH THE EYELET OF THE ANCHOR BEFORE INSERTION INTO THE BONE, CAUSING THE ANCHOR TO BE UNUSABLE AND UNABLE TO BE INSERTED. WHEN VIEWING THE FAILED ANCHOR ARTHROSCOPICALLY IT APPEARED THAT THE TIP RETENTION SUTURES HAD SERRATED AT THE APEX OF THE SUTURE THAT INTERFACES WITH THE SUTURE EYELET, CAUSING THE EYELET TO DETACH FROM THE INSERTER CAUSING THE ANCHOR TO FAIL. AFTER TWO ANCHORS MALFUNCTIONED, THE SURGEON USED A AR-2324BCCT AND UNLOADED THE FIBERTAPE TO USE FOR THE SUBSCAP REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 11946756 ↗