Arthrex® AR-5008Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867102699), received between Aug 24, 2020 and Apr 26, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Defective Device; Defective Device

  ON 08/17/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT TWO AR-5008 (LINE#1) 012045 AND (LINE#2) 012046 BLACK PROBE THE FINISH WAS RUBBING OFF ONTO THE 4X4 SPONGE. THIS WAS DISCOVERED BEFORE A SHOULDER PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED USING A DIFFERENT AR-5008.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192084 ↗
• MalfunctionApr 26, 2024Defective Device; Defective Device

  ON 08/17/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT TWO AR-5008 (LINE#1) 012045 AND (LINE#2) 012046 BLACK PROBE THE FINISH WAS RUBBING OFF ONTO THE 4X4 SPONGE. THIS WAS DISCOVERED BEFORE A SHOULDER PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED USING A DIFFERENT AR-5008.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192015 ↗
• MalfunctionNov 16, 2020Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PROBES HAVE BEEN LEAVING BLACK RESIDUE IN THE JOINT. THIS OCCURS EVEN IF THEY WIPE OFF THE PROBE PRIOR TO USE. IT WAS REPORTED THAT ALL 7 DEVICES FROM THEIR MOST RECENT ORDER RECEIVED (AR-5008, LOT 012039, QTY 7) HAVE THE SAME ISSUE. PRIOR SPECIFIC CASE INFORMATION WAS NOT AVAILABLE. THE SALES REP WAS PRESENT FOR THE MOST RECENT OCCURRENCE WHICH WAS A SHOULDER SCOPE THAT TOOK PLACE (B)(6) 2020. THE PART NUMBER IS AR-5008, PROBE-GRADUATED BLACK (LOT 012039). THE RESIDUE WAS LEFT IN THE PATIENT. THE DEVICE WAS REMOVED FROM THE CASE AFTER THE RESIDUE WAS DISCOVERED. ALL 7 OF THE DEVICES ARE AVAILABLE AND WILL BE RETURNED TO ARTHREX FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10842511 ↗
• InjuryAug 24, 2020Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PROCEDURE (KNEE ARTHROSCOPY, SYNOVECTOMY, CHONDROPLASTY, LATER RELEASE, TIBIA TUBERCLE OSTEOTOMY, MEDIAL PATELLOFEMORAL LIGAMENT REPAIR) A BRAND NEW AR-5008 (LOT 012023) ARTHREX PROBE WAS USED. THE PROBE LEFT BLACK RESIDUE MARKS ON THE SCRUB TECH'S HAND AND IN THE PATIENT. THE CASE WAS SLIGHTLY AFFECTED AS THE SURGEON REPORTED TO THE SALES REPRESENTATIVE THAT HE HAD TO PERFORM A WASHOUT TO GET THE BLACK MARKS OFF/OUT OF THE PATIENT. REP STATES THAT ACCORDING TO THE SURGEON HE WAS ABLE TO IRRIGATE AND REMOVE THE BLACK RESIDUE. SURGEON DID NOT CONTINUE TO USE THE PROBE THAT LEFT RESIDUE. IT WAS IMMEDIATELY REMOVED FROM THE PROCEDURE ONCE THE RESIDUE WAS DISCOVERED. THE FACILITY HAD RECENTLY PURCHASED THREE AR-5008 PROBES. UPON FURTHER INSPECTION OF THE REMAINING TWO UNOPENED PROBES IT WAS DISCOVERED THAT ALL THREE, WHICH WERE FROM THE SAME LOT, HAD BLACK RESIDUE WHICH COULD BE VISUALIZED IN THE UNOPENED PACKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10443109 ↗