Arthrex® AR-4550PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867307544), received between Jan 11, 2022 and Sep 18, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Overheating of Device; Dull, Blunt

  It was reported that during a surgery the Flipcutter from the Meniscal Root Repair set AR-4550 was extremely dull and became so hot that the bone "burned". Only with extreme pressure did the surgeon then get through and slipped posteriorly into the soft tissue. No further information received.Update 15-Sep-2026:Further information was provided that the affected device is the AR-4550P, LOT: 15491378.

  Patient problems: Insufficient Information

  MAUDE report 50817659 ↗
• InjuryFeb 13, 2026Patient Device Interaction Problem

  ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4550P MENISCAL ROOT REPAIR WITH PEEK SWIVELOCK IMPLANT SYSTEM HAD BEEN IMPLANTED RECENTLY AND THE PATIENT HAS AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 03-FEB-2026: IT WAS FURTHER REPORTED THAT THE INFECTION WAS LOCALIZED AND WAS IDENTIFIED AS AN MSSA INFECTION AND THE PATIENT IS NOW STABLE. THE ARTHREX PRODUCTS WERE INITIALLY IMPLANTED IN AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT, INTERNAL BRACE PROCEDURE FOR AN ACL TEAR. THE DEVICES HAVE SINCE BEEN EXPLANTED. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Bacterial Infection

  MAUDE report 24331359 ↗
• InjuryFeb 12, 2026Patient Device Interaction Problem

  ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4550P MENISCAL ROOT REPAIR WITH PEEK SWIVELOCK IMPLANT SYSTEM HAD BEEN IMPLANTED RECENTLY AND THE PATIENT HAS AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 03-FEB-2026: IT WAS FURTHER REPORTED THAT THE INFECTION WAS LOCALIZED AND WAS IDENTIFIED AS AN MSSA INFECTION AND THE PATIENT IS NOW STABLE. THE ARTHREX PRODUCTS WERE INITIALLY IMPLANTED IN AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT, INTERNAL BRACE PROCEDURE FOR AN ACL TEAR. THE DEVICES HAVE SINCE BEEN EXPLANTED. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Bacterial Infection

  MAUDE report 24324345 ↗
• MalfunctionJan 10, 2025Break; Break

  ON 12/13/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE SCORPION NEEDLE TIP FROM AN AR-4550P MENISCAL ROOT REPAIR WITH PEEK SWIVELOCK IMPLANT SYSTEM BROKE OFF WHEN THE SCORPION WAS DEPLOYED. THE FRAGMENTS WERE NOT RETRIEVED. THE SURGEON DETERMINED THE RISK OUTWEIGHED THE BENEFITS. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 21126213 ↗
• MalfunctionDec 13, 2024

  DURING DEPLOYMENT OF THE KNEE SCORPION NEEDLE A SMALL FRAGMENT OF THE METAL DISTAL TIP BROKE OFF THE SUTURING DEVICE. X-RAY WAS OBTAINED. THE MD DETERMINE RISK OUT WEIGHED THE BENEFITS. THE PATIENT WAS MADE AWARE AND WAS IN AGREEMENT WITH THE MD DECISION. MANUFACTURER RESPONSE FOR ARTHREX KNEE SCORPION NEEDLE, ARTHREX (PER SITE REPORTER). THIS WAS A LOANER FROM ARTHREX. ARTHREX REP [NAME REDACTED], WAS AWARE AND ADVISED TO DISPOSE OF PRODUCT ON 10/3/24.

  Patient problems: Foreign Body In Patient

  MAUDE report 20924010 ↗
• MalfunctionSep 12, 2024Break; Break

  ON 08/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SCORPION NEEDLE AND SWIVELOCK FROM AN AR-4550P MENISCAL ROOT REPAIR KIT BROKE. THIS WAS DISCOVERED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20202912 ↗
• MalfunctionJan 11, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN KNEE SCORPION FROM AR-4550P MENISCAL ROOT REPAIR KIT, TIP BROKE INSIDE THE BONE. THIS WAS DISCOVERED DURING A MENISCAL ROOT REPAIR ON (B)(6) 2021. THE BROKE TIP WAS LESS THAN 1MM AND COULD NOT BE RETRIEVED FROM INSIDE THE PATIENT. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/22/2021, SALES REPRESENTATIVE HAS CONFIRM THAT CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13225541 ↗