Arthrex® AR-14003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867016125), received between Aug 1, 2018 and May 3, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ORIF PROXIMAL HUMERUS SURGERY THE SCREW AR-14244 GOT STUCK IN THE HUMERAL PLATE AR- 14003 (LOT NUMBER: 15103696). THE SURGEON HAD TO REMOVE THE PLATE TOGETHER WITH THE SCREW AND A NEW PLATE HAD TO BE USED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237931 ↗
• InjuryAug 1, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROXIMAL SUTURE PLATE REMOVAL PROCEDURE, AS THE SURGEON WENT TO REMOVE THE SCREWS, THE SCREW TIPS ON EACH SCREW BECAME DETACHED AND REMAINED IN THE FAR CORTEX OF THE PATIENT'S HUMERUS. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE TIPS AND NO EXTRA SURGERY IS SCHEDULED TO REMOVE THE TIPS EITHER. THE PATIENT CONDITION WAS STABLE. HARDWARE REMOVED: AR-14003, AR-14128NL, AR-14124NL, AR-14242, AR-14240, AR-14236, AR-14234, AR-14126. ADDITIONAL INFORMATION PROVIDED 7/27/2018: THE REMOVAL SURGERY DATE WAS (B)(6) 2018. THE ORIGINAL SURGERY (FIRST IMPLANTED DATE) IS (B)(6) 2017. THE SCREWS AND PLATE WERE REMOVED AS THE ONE WAS HEALED. THE IMPLANTATION OF THE PLATE AND SCREWS WAS TEMPORARY. ALL EXPLANTED SCREWS WERE DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 7738640 ↗