Arthrex® AR-4550Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867217379), received between Jun 7, 2018 and Jun 9, 2024 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2024Break; Break

  ON 2/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-4550 MENISCAL ROOT REPAIR KIT HAD AN ISSUE DURING AN KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023. DESPITE MULTIPLE TRIES, THE NEEDLE WOULD NOT PASS THROUGH THE MENISCAL TISSUE ON FIRING THE SECOND FIBERLINK WITH THE KNEE SCORPION. ONCE THE NEEDLE WAS REMOVED, IT APPEARED TO PARTIALLY FRACTURE IN THE SHAFT OF THE NEEDLE; THE WHOLE NEEDLE WAS REMOVED - NO PARTS OF THE NEEDLE SPLIT OFF OR REMAINED IN THE PATIENT. THE CASE WAS COMPLETED USING A SEPARATE KNEE SCORPION NEEDLE. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495231 ↗
• MalfunctionMay 23, 2024Unraveled Material; Unraveled Material

  ON 10/21/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-4550 MENISCAL ROOT KIT FAILED AND THE SUTURE BECAME UNRAVELED. THE BUTTON NEVER DEPLOYED AND WAS NOT IMPLANTED. IT WAS REPLACED WITH ANOTHER AR-4550 AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. NO CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19382476 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR SURGERY THE SCORPION NEEDLE SNAPPED OFF INSIDE THE SCORPION AND IS STUCK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A MENISCAL RESECTION. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE SWIT 22-NOV-2022: NOTHING BROKE INSIDE THE PATIENT, THE NEEDLE BROKE OUTSIDE OF THE JOINT IN THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248048 ↗
• InjuryMar 8, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A KNEE SCORPION NEEDLE FROM AN AR-4550 MENISCAL ROOT REPAIR IMPLANT SYSTEM WAS DAMAGED AND BROKEN; THE SURGEON WAS ABLE TO REMOVE ALL BROKEN FRAGMENTS. AS A RESULT, THE MENISCAL ROOT REPAIR WAS NOT COMPLETED. THE SURGEON CHANGED TO AN ALL-INSIDE PROCEDURE, IN WHICH THREE CONSECUTIVE AR-4570 FIBERSTITCH COULD NOT DEPLOY THE SECOND IMPLANT DUE TO THE WHEEL GETTING STUCK. THE FIRST ANCHOR FOR EACH FIBERSTITCH WAS REMOVED FROM INSIDE THE PATIENT. THE CASE WAS CONDUCTED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 16501093 ↗
• MalfunctionMar 8, 2021Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE KNEE SCORPION NEEDLE BROKE OFF DURING SUTURE PASSING STEP OF LATERAL MENISCAL ROOT REPAIR. ALL FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED BY SUING A NEW KIT.

  Patient problems: Insufficient Information

  MAUDE report 11435839 ↗
• InjuryAug 24, 2020Material Rupture; Device Fell

  AN ARTHREX EMPLOYEE HAS REPORTED THAT AFTER THE SUCCESSFUL MENISCUS ROOT FIXATION THE SURGEON WANTED TO KNOT THE BUTTON ON THE BONE. THE BUTTON FELL INTO THE DRILL HOLE. THE SURGEON THEN TRIED TO REFIXATE THE SUTURE WITH A PUSH LOCK BUT IT RUPTURED. THE SURGEON WAS THEN ABLE TO FINISH THE SURGERY SUCCESSFULLY WITH A DIFFERENT TECHNIQUE AND AN ADDITIONAL SWIVELOCK. HOWEVER THE SURGEON WAS NOT ABLE TO RETRIEVE THE LOST BUTTON OUT OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10443229 ↗
• InjuryJan 27, 2020Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCUS ROOT REPAIR PROCEDURE, THE NEEDLE CONTAINED INSIDE OF THE MENISCAL ROOT KIT, AR-4550, JAMMED UP AND BROKE INSIDE OF THE KNEE SCORPION, AR-12990. THE NEEDLE WAS UNABLE TO BECOME DISENGAGED FROM THE SCORPION AND THE PROCEDURE WAS COMPLETED BY PERFORMING A PARTIAL MENISCECTOMY. ADDITIONAL INFORMATION PROVIDED 1/7/2020: THE NEEDLE WILL BE RETURNED WITH THE SCORPION AS IT IS STILL LODGED WITHIN THE DEVICE. NO ADDITIONAL INCISION WAS NEEDED TO COMPLETE THE PARTIAL MENISECTOMY. THERE WERE NO FRAGMENTS OF THE NEEDLE RETAINED IN THE PATIENT AND THE REST OF THE NEEDLE WAS DISPOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9631354 ↗
• InjuryOct 30, 2019Break

  THE FLIPCUTTER IN THE AR-4550 KIT WAS BEING USED DURING THE MENISCAL ROOT REPAIR. AFTER IT WAS DRILLED INTO THE TIBIA, THE FLIPCUTTER FELL APART INTO FOUR PIECES. THREE OF THE FOUR PIECES WERE RETRIEVED FROM THE PATIENT, THE FOURTH PIECE WAS NOT REMOVED AND WAS VISIBLE ON X-RAY. THEY USED AN ADDITIONAL INCISION TO TRY AND GET THE LAST PIECE BUT WERE UNSUCCESSFUL; IT IS IN THE POSTERIOR LATERAL PART OF THE KNEE. THE CASE WAS COMPLETED; PATIENT IS MALE, (B)(6) YEARS OLD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9255228 ↗
• InjuryJul 16, 2018Break; Detachment of Device or Device Component

  IT WAS DISCOVERED DURING MONTHLY MAUDE REVIEW THAT A FACILITY HAD REPORTED THE FOLLOWING: THE ARTHREX COMPONENT OF AN AR-4550, KNEE SCORPION NEEDLE, HAD THE TIP BREAK OFF IN PATIENT'S KNEE JOINT DURING SURGERY AND WAS SEEN ON X-RAY POST OP. SURGEON CHOSE TO MONITOR PATIENT AND NOT GO IN AFTER THE TIP. MAUDE REPORT CONTAINED NO FACILITY OR REPORTER NAME/CONTACT INFORMATION. THEREFORE NO FOLLOW UP IS POSSIBLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7691664 ↗
• InjuryJun 7, 2018Detachment Of Device Component

  IT REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE TIP OF THE SCORPION NEEDLE (LOT: 10034428) BROKE OFF INTO THE PATIENT'S KNEE JOINT. THE CASE WAS COMPLETED WITH THE SAME NEEDLE. IT WASN'T NOTICED THAT THE TIP HAD BROKEN OFF UNTIL A POST-OP X-RAY WAS TAKEN AND THE TIP WAS SEEN IN JOINT SPACE. THE SURGEON IS COMFORTABLE LEAVING THE TIP IN THE KNEE. REPORTER HAD NO ADDITIONAL INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7577713 ↗