Arthrex® AR-8942R-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867051997), received between Mar 9, 2020 and Jan 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON 12/12/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06428823 THAT AN AR-8942R-06 LOW PROFILE H-PLATE, TI, 6 MM WEDGE, RIGHT WAS REMOVED DURING A REVISION DISTAL TIBIA OPENING WEDGE PROCEDURE ON (B)(6) 2023. THE PRIMARY REPAIR FAILED; THE SCREWS BROKE. DURING THE REVISION SURGERY, THE SURGEON NOTICED THAT THE PLATE HAD MELTED DEBRIS ON TOP. THE PLATE WAS REMOVED CAREFULLY BECAUSE THE MELTED DEBRIS ITSELF WAS ATTACHED TO THE PATIENT'S SOFT TISSUE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 18487823 ↗
• InjuryMar 9, 2020Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD ANKLE RECONSTRUCTION SURGERY A FEW YEARS AGO UTILIZING ARTHREX PRODUCTS. SINCE SURGERY SHE HAS DEVELOPED REACTION TYPE SYMPTOMS WHICH INCLUDE RASHES AT THE SURGICAL SITE. PATIENT IS SEEKING MATERIAL COMPOSITION OF THE DEVICES. PATIENT WILL PROVIDE ADDITIONAL INFORMATION VIA EMAIL AND WILL OBTAIN THE SPECIFIC PART NUMBERS INVOLVED TO PROVIDE TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 02/17/2020: PATIENT'S SURGERY TOOK PLACE (B)(6) 2013. PROCEDURE WAS ON HER RIGHT FOOT. SHE HAD AN ACCESSORY NAVICULAR REMOVED AND THE ARCH IN HER FOOT WAS CORRECTED. PATIENT REPORTS HER ANKLE HAS ALWAYS BEEN TENDER BUT SHE FIGURED THAT WAS NORMAL (LONG LASTING EFFECTS OF SURGERY). SHE BEGAN HAVING RASHES ON HER KNUCKLES AROUND THE END OF 2016. IN THE PAST YEAR SHE HAS HAD RASHES ON HER SHINS; WHAT LOOKS LIKE POLPHOLYX ON HER FINGERS THAT COMES AND GOES; AND A SMALL PATCH OF DRY/ CRUSTY SKIN ON HER OUTER RIGHT ANKLE. THE ONLY THING THAT SEEMS TO HELP THE PATIENT IS ORAL BENADRYL. IN (B)(6) 2018 PATIENT'S EYESIGHT SUDDENLY BECAME SENSITIZED TO HIGH CONTRACT IMAGES/ LIGHTING. PATIENT HAS HEADACHES MORE OFTEN THAN EVER BEFORE. PATIENT'S OPHTHALMOLOGIST SAYS THE S

  Patient problems: Headache; Rash

  MAUDE report 9805055 ↗