Arthrex® AR-4500Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00888867033535), received between Jul 19, 2016 and Jan 23, 2026 — classified as 48 injuries, 49 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Detachment of Device or Device Component

  ON 8TH JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4500, MENISCAL CINCH¿, BOTH ANCHORS DROPPED OUT WHEN THE FIRST BUTTON WAS PUSH. THIS WAS DETECTED DURING A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT OF THE RIGHT KNEE JOINT AND MENISCUS SUTURE SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4500. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159972 ↗
• MalfunctionMay 16, 2025Positioning Failure; Positioning Failure

  ON 29 APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR A TOTAL OF 4 UNITS OF AR-4500, MENISCAL CINCH, BOTH IMPLANTS FAILED TO SET. THIS WAS DETECTED DURING AN RIGHT KNEE MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TOTAL USE OF 8 UNITS OF AR-4500; 4 SUCCEEDED AND 4 FAILED. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED. THE KNOT PUSHER/CUTTER TYPE IS AR-4515.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036000 ↗
• MalfunctionMay 16, 2025Positioning Failure; Positioning Failure

  ON 29 APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR A TOTAL OF 4 UNITS OF AR-4500, MENISCAL CINCH, BOTH IMPLANTS FAILED TO SET. THIS WAS DETECTED DURING AN RIGHT KNEE MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TOTAL USE OF 8 UNITS OF AR-4500; 4 SUCCEEDED AND 4 FAILED. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED. THE KNOT PUSHER/CUTTER TYPE IS AR-4515.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035795 ↗
• MalfunctionMay 16, 2025Positioning Failure; Positioning Failure

  ON 29 APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR A TOTAL OF 4 UNITS OF AR-4500, MENISCAL CINCH, BOTH IMPLANTS FAILED TO SET. THIS WAS DETECTED DURING AN RIGHT KNEE MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TOTAL USE OF 8 UNITS OF AR-4500; 4 SUCCEEDED AND 4 FAILED. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED. THE KNOT PUSHER/CUTTER TYPE IS AR-4515.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035486 ↗
• MalfunctionMay 16, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR A TOTAL OF 4 UNITS OF AR-4500, MENISCAL CINCH, BOTH IMPLANTS FAILED TO SET. THIS WAS DETECTED DURING AN RIGHT KNEE MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TOTAL USE OF 8 UNITS OF AR-4500; 4 SUCCEEDED AND 4 FAILED. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED. THE KNOT PUSHER/CUTTER TYPE IS AR-4515.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035266 ↗
• MalfunctionApr 30, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-4500, MENISCAL CINCH, BOTH IMPLANTS FAILED TO SET. THIS WAS DETECTED DURING AN ARTHROSCOPIC CLEARANCE, MENISCUS SUTURE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4500. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED. THE KNOT PUSHER/CUTTER TYPE IS AR-4515.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937703 ↗
• MalfunctionApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2ND APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-4500, MENISCAL CINCH, THE ANCHOR WAS PULLED OUT. THIS WAS DETECTED DURING A MENISCUS REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4500. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.THE KNOT PUSHER/CUTTER TYPE IS AR-4515.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859574 ↗
• MalfunctionSep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-4500, MENISCAL CINCH, WHEN A SURGEON TRIED TO DEPLOY THE IMPLANT, IT FELL OFF. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER NEW AR-4500. THIS WAS DISCOVERED DURING A MENISCUS REPAIR PROCEDURE ON (B)(6) 2024. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310585 ↗
• MalfunctionJul 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 1ST JULY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-4500, MENISCAL CINCH, THE SECOND IMPLANT SET FELL OUT BEFORE THE BUTTON WAS PUSHED. THE FIRST IMPLANT SET WAS PROPERLY PLACED BUT THE SECOND ONE FELL OUT BEFORE THE BUTTON WAS PUSHED. THE SURGEON USED ANOTHER AR-4500 TO COMPLETE THE PROCEDURE, BUT THE SAME SITUATION HAPPENED AGAIN. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER NEW AR-4500. THIS WAS DISCOVERED DURING A MENISCUS REPAIR PROCEDURE ON (B)(6) 2024. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827457 ↗
• MalfunctionJun 27, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4500 MENISCAL CINCH DID NOT DEPLOY THE SECOND ANCHOR. THE SURGEON ATTEMPTED TO DEPLOY THE SECOND ANCHOR THREE TIMES BUT COULD NOT. THE PROCEDURE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING AN ACLR AND MENCIUS REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 7/27/2023: THE FIRST ANCHOR WAS REMOVED; HOWEVER, THE CASE WAS DELAYED NEARLY THIRTY MINUTES, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NOTHING BROKE OFF INSIDE THE PATIENT. THE SAME ISSUE OCCURRED WITH TWO OTHER AR-4500 MENISCAL CINCH.

  Patient problems: Insufficient Information

  MAUDE report 19623673 ↗
• MalfunctionJun 27, 2024Failure to Advance; Failure to Advance

  ON 7/19/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4500 MENISCAL CINCH DID NOT DEPLOY THE SECOND ANCHOR. THE SURGEON ATTEMPTED TO DEPLOY THE SECOND ANCHOR THREE TIMES BUT COULD NOT. THE PROCEDURE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING AN ACLR AND MENCIUS REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 7/27/2023: THE FIRST ANCHOR WAS REMOVED; HOWEVER, THE CASE WAS DELAYED NEARLY THIRTY MINUTES, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NOTHING BROKE OFF INSIDE THE PATIENT. THE SAME ISSUE OCCURRED WITH TWO OTHER AR-4500 MENISCAL CINCH.

  Patient problems: Insufficient Information

  MAUDE report 19623595 ↗
• MalfunctionJun 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SURGEON FOUND THAT THE PEEK IMPLANT WAS STUCK IN THE NEEDLE AND COULD NOT BE IMPLANTED ON AN AR-4500. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537403 ↗
• MalfunctionJun 14, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, DURING AN MR SURGERY, THE BACKSTOP DID NOT LOCK ON BACK OF MENISCUS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19537311 ↗
• InjuryJun 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 5/15/2024: THE PATIENT HAS NOT UNDERGONE REVISION SURGERY, AND NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT.

  Patient problems: Unspecified Infection

  MAUDE report 19532404 ↗
• MalfunctionJun 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 8/17/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA E-MAIL THAT AN AR-4500 MENISCAL CINCH COULD NOT DEPLOY THE SECOND ANCHOR; THE ANCHOR DID NOT COME LOOSE FROM THE NEEDLE. DUE TO DEVICE FAILURE, THE SURGEON COMPLETED THE PROCEDURE AS A MENISCECTOMY ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 8/18/2023: TWO AR-45700 MENISCAL CINCH FAILED DURING THIS PROCEDURE. THE FIRST MENISCAL CINCH COULD NOT DEPLOY THE SECOND ANCHOR; IT GOT STUCK IN THE NEEDLE. THE SURGEON WAS ABLE TO REMOVE THE FIRST ANCHOR. A SECOND MENISCAL CINCH WAS OPENED, AND THE SAME HAPPENED; THE SECOND ANCHOR COULD NOT BE DEPLOYED AS IT GOT STUCK IN THE NEEDLE. THE SURGEON USED A SCORPION NEEDLE TO FINISH THE STITCH WITH THE REMAINING SUTURE FROM THE MENISCAL CINCH. THE FIRST ANCHOR REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19524300 ↗
• MalfunctionJun 11, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE DEVICE PREMATURELY DEPLOYED. BOTH IMPLANTS WERE REMOVED FROM THE PATIENT AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. SEE SOURCE DATA ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514908 ↗
• MalfunctionJun 11, 2024Failure to Fire; Failure to Fire

  ON 5/16/2023 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4500 MENISCAL CINCH DID NOT DEPLOY THE FIRST ANCHOR. THE CASE WAS COMPLETED USING ANOTHER AR-4500 MENISCAL CINCH FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 19510094 ↗
• MalfunctionJun 11, 2024Positioning Failure; Positioning Failure

  ON 2/17/2022 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4500 MENISCAL CINCH FIRST ANCHOR WAS DEPLOYED BUT WHEN THE SECOND ANCHOR WAS DEPLOYED, IT COULD NOT BE LOCATED. SURGEON OPENED A NEW MENISCAL CINCH AND THE SECOND ANCHOR DEPLOYED WAS LOOSE. TO COMPLETE CASE, SURGEON USED A THIRD MENISCAL CINCH FROM DIFFERENT LOT. NO FURTHER ISSUES WERE REPORTED. THIS WAS DISCOVERED DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 2/21/2022: WHILE USING THE FIRST AR-4500 MENISCAL CINCH, THE SECOND ANCHOR DID NOT DEPLOY AND SURGEON COULD NOT FIND THE ANCHOR WHEN THE TIP WAS PUSHED. SURGEON CUT OUT THE SUTURES AND REMOVED THE FIRST ANCHOR. A SECOND AR-4500 MENISCAL CINCH WAS OPENED AND BECAUSE THE SECOND ANCHOR DID NOT SEAT AND WAS TOO LOOSE, SURGEON CUT OUT THE SUTURES AND REMOVED BOTH ANCHORS. CASE WAS COMPLETED USING A THIRD MENISCAL CINCH.

  Patient problems: Insufficient Information

  MAUDE report 19509833 ↗
• MalfunctionJun 11, 2024Positioning Failure; Positioning Failure

  ON 2/17/2022 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4500 MENISCAL CINCH FIRST ANCHOR WAS DEPLOYED BUT WHEN THE SECOND ANCHOR WAS DEPLOYED, IT COULD NOT BE LOCATED. SURGEON OPENED A NEW MENISCAL CINCH AND THE SECOND ANCHOR DEPLOYED WAS LOOSE. TO COMPLETE CASE, SURGEON USED A THIRD MENISCAL CINCH FROM DIFFERENT LOT. NO FURTHER ISSUES WERE REPORTED. THIS WAS DISCOVERED DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022 ADDITIONAL INFORMATION RECEIVED 2/21/2022: WHILE USING THE FIRST AR-4500 MENISCAL CINCH, THE SECOND ANCHOR DID NOT DEPLOY AND SURGEON COULD NOT FIND THE ANCHOR WHEN THE TIP WAS PUSHED. SURGEON CUT OUT THE SUTURES AND REMOVED THE FIRST ANCHOR. A SECOND AR-4500 MENISCAL CINCH WAS OPENED AND BECAUSE THE SECOND ANCHOR DID NOT SEAT AND WAS TOO LOOSE, SURGEON CUT OUT THE SUTURES AND REMOVED BOTH ANCHORS. CASE WAS COMPLETED USING A THIRD MENISCAL CINCH.

  Patient problems: Insufficient Information

  MAUDE report 19509831 ↗
• MalfunctionJun 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING ACL AND MENISCUS REPAIR SURGERY IT WAS DIFFICULT TO INSERT THE FIRST IMPLANT AND THE SECOND IMPLANT DID NOT COME OFF THE NEEDLE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504420 ↗
• MalfunctionJun 7, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A MR SURGERY THE BACKSTOP DID NOT LOCK ON BACK OF MENISCUS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19488220 ↗
• MalfunctionMay 14, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON 12/21/20210, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4500 MENISCAL CINCH WOULD NOT DEPLOY IMPLANT WHEN #1 NEEDLE WAS PUSHED OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 12/23/2021: THIS WAS DISCOVERED DURING A MENISCAL REPAIR PROCEDURE AND NOTHING BROKE INSIDE THE PATIENT. SURGEON WAS ABLE TO COMPLETE CASE USING AN AR-4500 FROM THE SAME LOT NUMBER WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19317083 ↗
• MalfunctionMay 9, 2024Mechanical Jam; Mechanical Jam

  ON 12/21/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4500 MENISCAL CINCH SUTURE GOT STUCK. THIS WAS DISCOVERED DURING A MENISCAL REPAIR PROCEDURE ON (B)(6)2021. SURGEON OPENED ANOTHER AR-4500 FROM ANOTHER LOT AND CASE WAS COMPLETED SUCCESSFUL WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19282887 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE SURGEON IMPLANTED THE BACK STOP NUMBER ONE AND TWO AND STARTED FOR TENSION THE FIBER WIRE, THE BACK STOP PULLED OUT. 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 SWIT 06-JUL-2022: ANOTHER CINCH WAS USED AND THEY FIXED THE MINSCUSES SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280856 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY, AFTER IMPLANTATION OF THE FIRST IMPLANT, BACK STOP WHEN STARTING FOR TENSION THE BACK STOP PULLED OUT. AFTER IMPLANTATION OF THE SECOND ONE, THE FIBERWIRE CUT THROUGH DURING TENSION FROM THE DISTAL SIDE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277139 ↗