Arthrex® AR-4551Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00888867425316), received between Oct 27, 2023 and Sep 8, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Break

  It was reported that the device broke out post-operatively. The device was initially implanted on(b)(6)2026. The revision surgery was successfully performed on (b)(6)2026 with a new AR-4551. It is assumed that this occurred due to premature weight-bearing by the patient.

  Patient problems: Failure of Implant

  MAUDE report 50671861 ↗
• MalfunctionFeb 27, 2026Break

  ON 10-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT EXPERIENCED AN ISSUE DURING A MENISCAL ROOT REPAIR PROCEDURE PERFORMED ON (B)(6) 2026. WHILE DRILLING THE TIBIA, THE DRILL PIN FRACTURED INTO TWO PIECES. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. A REPLACEMENT AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. THE EVENT RESULTED IN LESS THAN 15 MINUTES OF PROCEDURAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470829 ↗
• MalfunctionFeb 13, 2026Device Dislodged or Dislocated

  ON 27-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC, AND AN AR-1588RTT2-IB FIBERTAG® TIGHTROPE FAILED DURING USE. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2026 WHEN THE AR-4551 SUTURELOC ANCHOR PULLED THROUGH THE TIBIA. THE AR-1588RTT2-IB FIBERTAG® TIGHTROPES SUTURE BROKE AT THE BUTTON. ALL PORTIONS OF THE AR-4551 WERE REMOVED FROM THE PATIENT, WHILE THE SUTURE FROM THE AR-1588RTT2-IB WAS ATTACHED TO THE GRAFT AND REMAINS IN THE PATIENT, BUT THE BUTTON WAS REMOVED. THE PROCEDURE CONTINUED USING DEVICES FROM ANOTHER MANUFACTURER. THIS EVENT RESULTED IN APPROXIMATELY A 30-MINUTE DELAY, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT HAD POOR BONE QUALITY, AND THE BONE WAS PREPPED WITH THE KIT'S DRILL. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332097 ↗
• MalfunctionFeb 3, 2026Break

  ON 13-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2026, AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT EXPERIENCED TWO ISSUES. FIRST, THE KNEE SCORPION NEEDLE BROKE WHILE PASSING THE SUTURE; THE FRAGMENT WAS RETRIEVED. SECOND, A PORTION OF THE PASSPORT BUTTON CANNULA BROKE DURING PLACEMENT IN THE PATIENT; THIS FRAGMENT WAS ALSO RETRIEVED. THE CASE WAS DELAYED APPROXIMATELY 15 MINUTES, REQUIRING ADDITIONAL ANESTHESIA. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-JAN-2026: THE AR-12990 KNEE SCORPION DEVICE WAS USED WITH THE KNEE SCORPION NEEDLE DURING THE PROCEDURE. NO DAMAGE WAS REPORTED TO THE AR-12990 KNEE SCORPION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246049 ↗
• MalfunctionJan 12, 2026Positioning Failure

  ON 24-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT TWO AR-4551 SUTURELOC MENISCAL ROOT REPAIR KITS FAILED TO SET DURING IMPLANTATION. BOTH IMPLANTS WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING ARTHREX FIBERLINKS AND AN AR-8922 SUTURE BUTTON (12 MM). THE ISSUE RESULTED IN A 15-MINUTE DELAY IN THE CASE, AND IT IS UNCERTAIN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE QUALITY WAS ASSESSED AS GOOD. THIS OCCURRED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037397 ↗
• MalfunctionJan 12, 2026Positioning Failure

  ON 24-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT TWO AR-4551 SUTURELOC MENISCAL ROOT REPAIR KITS FAILED TO SET DURING IMPLANTATION. BOTH IMPLANTS WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING ARTHREX FIBERLINKS AND AN AR-8922 SUTURE BUTTON (12 MM). THE ISSUE RESULTED IN A 15-MINUTE DELAY IN THE CASE, AND IT IS UNCERTAIN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE QUALITY WAS ASSESSED AS GOOD. THIS OCCURRED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037069 ↗
• MalfunctionNov 26, 2025Positioning Failure; Positioning Failure

  ON 11/07/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT MALFUNCTIONED DURING A MENISCAL ROOT REPAIR PROCEDURE. THE ISSUE OCCURRED DURING THE FINAL TENSIONING STEP, WHERE THE WHITE AND BLUE SUTURES FAILED TO LOCK INTO THE IMPLANT OR MAINTAIN TENSION. SUBSEQUENTLY, THE SUTURES WERE PULLED ALL THE WAY OUT. THE CASE WAS COMPLETED BY REMOVING THE WHOLE IMPLANT AND USING A REPLACEMENT AR-4551 KIT FROM A DIFFERENT LOT, WHICH FUNCTIONED AS INTENDED. THE INCIDENT RESULTED IN A 30-MINUTE DELAY TO THE CASE; HOWEVER, IT REMAINS UNCERTAIN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED AS A RESULT OF THE DELAY. BONE PREPARATION FOR IMPLANT INSERTION WAS PERFORMED USING THE AR-1610H MENISCUS ROOT MARKING HOOK AND THE DRILL PIN INCLUDED IN THE KIT. THE BONE QUALITY WAS DESCRIBED AS GOOD AND YOUNG. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660025 ↗
• MalfunctionNov 17, 2025Positioning Failure; Positioning Failure

  ON 10/30/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT EXPERIENCED A MALFUNCTION DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025. ONCE THE SUTURELOC IMPLANT WAS PLACED INSIDE THE TIBIAL TUNNEL, THE TENSIONING LOOP WAS PULLED MULTIPLE TIMES IN AN ATTEMPT TO BUNCH THE IMPLANT. DESPITE REPEATED EFFORTS, THE IMPLANT FAILED TO BUNCH AND HOLD AS INTENDED. ULTIMATELY, THE IMPLANT WAS ABLE TO BE COMPLETELY REMOVED FROM THE TIBIAL TUNNEL, AS IT NEVER FULLY SET. A NEW AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11/07/2025: THE CASE WAS DELAYED 10 MINUTES, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE BONE PREPARATION FOR IMPLANT INSERTION WAS PERFORMED USING THE 2.4 MM CANNULATED DRILL FROM THE AR-4551 KIT, AND THE BONE QUALITY WAS ASSESSED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567712 ↗
• InjuryNov 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 10/23/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT EXPERIENCED AN IMPLANT-RELATED ISSUE. THE DEVICE WAS IMPLANTED ON (B)(6) 2025 TO REPAIR THE LATERAL MENISCAL ROOT. THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY OR COMPLICATION. THIRTEEN WEEKS POST-IMPLANTATION, THE PATIENT RETURNED TO THE CLINIC REPORTING KNEE STIFFNESS. AN ATTEMPTED JOINT MANIPULATION IN THE OFFICE WAS NOT WELL TOLERATED BY THE PATIENT. ON (B)(6) 2025, A MANIPULATION UNDER ANESTHESIA AND KNEE ARTHROSCOPY WERE PERFORMED. DURING THE ARTHROSCOPY, ONE OF THE REPAIR SUTURES (BLUE) FROM THE AR-4551 DEVICE WAS FOUND TO BE LOOSE. UPON PROBING, THE TAIL OF THE BLUE SUTURE WAS OBSERVED WITHIN THE JOINT, INDICATING THAT THE KNOTLESS MECHANISM OF THE DEVICE WAS NOT MAINTAINING TENSION ON THE BLUE REPAIR SUTURE. THE WHITE REPAIR SUTURE APPEARED TO RETAIN APPROPRIATE TENSION. THE LOOSE BLUE SUTURE WAS PARTIALLY REMOVED, WHILE THE WHITE SUTURE WAS LEFT INTACT. ADDITIONAL INFORMATION WAS RECEIVED ON 10/28/2025: THE PATIENT UNDERWENT JOINT MANIPULATION IN THE OFFICE ON (B)(6) 2025. THE PATIENT IS DOING WELL AFTER THE MANIPULATION UNDER ANESTHESIA AND KNEE ARTHRO

  Patient problems: Failure of Implant

  MAUDE report 23463330 ↗
• MalfunctionOct 16, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT EXPERIENCED AN ISSUE DURING USE. THE ANCHOR FAILED TO PARTIALLY SET AND COULD NOT BE SEATED PROPERLY. DURING THE ATTEMPT TO PULL THE TENSIONING SUTURE THROUGH THE TIBIA, THE SUTURE SNAPPED. THE FAILED IMPLANT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT FROM A DIFFERENT LOT. THE ONLY DELAY REPORTED WAS THE TIME REQUIRED TO OPEN A NEW BOX. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT'S BONE QUALITY WAS ASSESSED AS AVERAGE, AND BONE PREPARATION WAS PERFORMED USING THE 2.4 MM DRILL INCLUDED IN THE KIT. THE ISSUE WAS DISCOVERED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311112 ↗
• MalfunctionAug 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/04/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC, MENISCAL ROOT REPAIR KIT EXPERIENCED AN ISSUE DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025. SPECIFICALLY, THE SECOND PASSING STITCH WAS INADVERTENTLY PULLED OUT WHILE THE FIRST REPAIR STITCH WAS PASSED THROUGH THE MENISCUS REPAIR SITE. AS A RESULT, THE SECOND STITCH COULD NOT BE PASSED, AND THE IMPLANT WAS REMOVED FROM THE PATIENT. A SECOND AR-4551 SUTURELOC KIT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872084 ↗
• MalfunctionAug 4, 2025Positioning Failure; Positioning Failure

  ON 7/15/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC, MENISCAL ROOT REPAIR KIT, HAD AN ISSUE DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS TRYING TO INSERT THE IMPLANT, IT WOULD NOT SEAT INTO THE TIBIA. THE IMPLANT WAS REMOVED FROM THE PATIENT IN ONE PIECE, NOTHING BROKE, AND THERE WAS NO HARM. ANOTHER AR-4551 SUTURELOC, MENISCAL ROOT REPAIR KIT, WITH A DIFFERENT LOT NUMBER, 15353524, WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700924 ↗
• MalfunctionJul 23, 2025Break; Break

  ON 07/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4551 IMPLANT SYSTEM SUTURELOC DEVICE BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583536 ↗
• MalfunctionJul 9, 2025Break; Break

  ON 06/16/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOCS SUTURE BROKE. THIS OCCURRED DURING A MENISCAL ROOT REPAIR ON (B)(6) 2025, WHEN PASSING THE SUTURE THROUGH THE MENISCUS, THE SUTURE RIPPED. THE DEVICE WAS CUT OUT. THE CASE WAS COMPLETED THE OLD WAY USING A SWIVELOC AND PASSING A FIBERTAK. THIS RESULTED IN A 20-MINUTE PROCEDURE, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460131 ↗
• MalfunctionJul 2, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT WAS USED DURING A MENISCAL ROOT REPAIR PROCEDURE PERFORMED ON (B)(6) 2025. THE IMPLANT WAS INSERTED AND TENSIONED WITHOUT INCIDENT. HOWEVER, FOLLOWING KNEE CYCLING BY THE SURGEON, THE CONSTRUCT LOOSENED. IT WAS RETENSIONED AND TIGHTENED BUT LOOSENED AGAIN AFTER PROBING BENEATH THE MENISCUS AT THE ROOT. DESPITE FURTHER RETIGHTENING OF THE TENSIONING SUTURES, THE CONSTRUCT REPEATEDLY LOOSENED. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT HARM WAS REPORTED. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 06/23/2025: TO COMPLETE THE PROCEDURE, THE SURGICAL TEAM FED THE SUTURELOC INTO A 4.75 MM SWIVELOCK. A 4.0 MM DRILL WAS USED TO BREACH THE CORTEX OF THE ANTEROMEDIAL TIBIA, FOLLOWED BY THE INSERTION OF A 4.75 MM SWIVELOCK TAP AND THEN THE SWIVELOCK ITSELF. THE CASE WAS COMPLETED USING PRODUCT PART NUMBER AR-2324PSLC. THE SURGERY WAS EXTENDED BY APPROXIMATELY 10 MINUTES. THERE IS NO CONFIRMED INFORMATION REGARDING THE ADMINISTRATION OF ADDITIONAL ANESTHESIA, THOUGH IT IS NOT BELIEVED TO HAVE BEEN NECESSARY. NO ADVERSE EFFECTS OR SIGNIFICANT PAT

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386901 ↗
• MalfunctionMay 21, 2025Break; Patient Device Interaction Problem; Material Split, Cut or Torn; Break; Patient Device Interaction Problem; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED ON 5/22/2025: DURING THE PROCEDURE, AN AR-4551 SUTURELOC DEVICE MALFUNCTIONED WHEN THE SHEATH BEGAN TO SPLICE, CAUSING IT TO BUNCH UP IRREGULARLY. THE MALFUNCTION OCCURRED INSIDE THE PATIENT, RESULTING IN PIECES OF THE IMPLANT BREAKING. HOWEVER, ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. AN ADDITIONAL 15 MINUTES OF ANESTHESIA WAS REQUIRED DUE TO THE CASE DELAY AT THIS TIME, THERE ARE NO REPORTED NEGATIVE EFFECTS OR SIGNIFICANT DAMAGE TO THE PATIENT POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061140 ↗
• MalfunctionApr 22, 2025Break; Break

  ON 4/3/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE TIP OF THE KNEE SCORPION FROM AN AR-4551 BROKE OFF IN THE PATIENT'S RIGHT KNEE. THE C-ARM WAS BROUGHT INTO THE ROOM TO VISUALIZE AND REMOVE THE FRAGMENT FROM THE PATIENT'S KNEE. THE CASE WAS COMPLETED AS USUAL. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21882348 ↗
• MalfunctionFeb 25, 2025Use of Device Problem; Use of Device Problem

  ON 02/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4551 MENISCAL ROOT REPAIR KIT SUTURELOC MALFUNCTIONED. NO PIECES BROKE OFF IN THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A MENISCAL ROOT REPAIR PROCEDURE (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459793 ↗
• MalfunctionFeb 18, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4551 SUTURELOC KIT IMPLANT LOOSENED AFTER FINAL TENSION AND IMPLEMENTATION OF THE KNEE. THIS OCCURRED DURING USE IN A MENISCUS ROOT REPAIR WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING SWIVELLOCK TO SECURE FINAL FIXATION. 10 MINUTES ADDED TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399575 ↗
• MalfunctionJan 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4551 SUTURELOCS SHUTTLING MECHANISM THROUGH THE SHEATH MALFUNCTIONED, THE FIRST REPAIR SUTURE DID NOT SHUTTLE ALL THE WAY THROUGH AS INTENDED, AND THE SHEATH PORTION PULLED OUT THE TIBIA. THIS OCCURRED DURING A MENISCAL ROOT REPAIR ON (B)(6) 2024. THE CASE WAS COMPLETED USING AN AR-1593-P IMPLANT SYSTEM. THERE WAS NO PATIENT HARM. THERE WAS A 5-MINUTE DELAY THAT REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066527 ↗
• MalfunctionDec 31, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/6/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SHUTTLING SUTURES AT THE BOTTOM OF THE IMPLANT OF AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT WERE STUCK TOGETHER AND THE KNOTLESS MECHANISM WOULD NOT LOCK. THE IMPLANT HAD TO BE BACKED UP WITH A SECONDARY FIXATION KIT TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/3/2024: IT WAS REPORTED THAT THE SCORPION NEEDLE BROKE INSIDE THE SCORPION. THE ANCHOR REMAINS IN THE PATIENT, BUT ALL OTHER FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING ANOTHER AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT. THE CASE WAS DELAYED BETWEEN FIFTEEN TO TWENTY MINUTES; HOWEVER, THE SALES REPRESENTATIVE DID NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21048765 ↗
• MalfunctionOct 9, 2024Break; Break

  ON 9/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4551 SUTURELOC, MENISCAL ROOT REPAIR KIT HAD AN ISSUE. DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2024, THE IMPLANT WAS IMPLANTED, THEN BOTH SHUTTLING SUTURES BROKE INSIDE THE PATIENT UPON SHUTTLING. THE SUTURES WERE REMOVED, THE IMPLANT WAS THEN EXPLANTED IN ONE PIECE, AND NOTHING BROKE OFF INSIDE THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED, NO PICTURES WERE TAKEN, AND THERE WAS NO HARM TO THE PATIENT. ANOTHER AR-4551 SUTURELOC, MENISCAL ROOT REPAIR KIT WITH THE SAME LOT NUMBER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CASE DELAY AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20411717 ↗
• MalfunctionOct 9, 2024Material Frayed; Material Frayed

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT SUTURES WERE SHREDDED. AFTER DRILLING WITH THE 2.4 CANNULATED PIN AND SHUTTLING THE SUTURE LASSO UP THE CANNULATED PIN, THE IMPLANTED WAS SHUTTLED DOWN. WHEN THE ANCHOR PORTION OF THE IMPLANTS REACHED THE TIBIAL PLATEAU, IT WAS NOTICED THAT THE SHEATH ON THE MECHANISM THAT BALLS UP WAS SHREDDED. THIS WAS DISCOVERED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 9/30/2024: THE SUTURES DID NOT BREAK OFF WHILE IN THE JOINT. THE CASE WAS COMPLETED USING ANOTHER AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT. THE CASE WAS DELAYED FOR ABOUT FIVE MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 20410148 ↗
• MalfunctionOct 1, 2024Break; Break

  ON 09/20/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC HAD THE STYLET FROM THE CANNULATED DRILL BROKEN OFF IN THE DRILL. NOTHING FELL INSIDE THE PATIENT, AND EVERYTHING WAS RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER AR-4551 SUTURELOC FROM THE SAME LOT WITH NO ISSUES. THERE WAS NO CASE DELAY REPORTED. THIS WAS DISCOVERED DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347435 ↗
• MalfunctionSep 30, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE SCORPION NEEDLE FROM AN AR-4551 SUTURELOC MENISCAL ROOT REPAIR KIT TIP BROKE IN THE PATIENT'S KNEE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20332077 ↗