Arthrex® AR-14005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867016149), received between Dec 19, 2016 and Dec 26, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Positioning Failure; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6)2026:ON (b)(6)2025, THE FAILED PROXIMAL HUMERAL PLATE WAS INITIALLY IDENTIFIED DURING A CLINIC VISIT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED. PER COMMUNICATION FROM THE OPERATIVE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE BUSHINGS WERE OBSERVED TO HAVE DISENGAGED FROM THE PLATE. ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ALL IMPLANTED ARTHREX DEVICES FROM THE REVISION PROXIMAL HUMERUS ORIF PERFORMED ON (b)(6)2025 WERE EXPLANTED DURING A SUBSEQUENT REVISION PROXIMAL HUMERUS PROCEDURE WITH PLACEMENT OF A SPACER ON (b)(6) 2026. NO ARTHREX IMPLANTS WERE IMPLANTED DURING THE (b)(6) 2026 PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED AT THE SAME FACILITY AS THE PRIOR REVISION PROXIMAL HUMERUS ORIF CONDUCTED ON (b)(6)2025; HOWEVER, THE PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS STABLE. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE (b)(6) 2026 SURGERY AND REPORTED BEING INFORMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS SCHEDULED TO UNDERGO A TOTAL SHOULDER REPLACEMENT IN MAY.ADDITIONAL INFORMATION WAS

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23896594 ↗
• MalfunctionFeb 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROXIMAL HUMERAL FRACTURE THE VARIABLE LOCKING BUSHING BROKE OUT OF THE PLATE. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18624872 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA PHONE THAT A AR-14005 HUMERAL SUTUREPLATES BUSHINGS ON THE PLATE FELL OFF. THIS OCCURRED ON (B)(6) 2022. DURING A HUMERAL FRACTURE. ALL FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER PLATE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074944 ↗
• 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 PATIENTS 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. ADDITIONAL HARDWARE WAS REMOVED AS WELL, HOWEVER, THE PART AND LOT NUMBERS ARE UNKNOWN. ADDITIONAL INFORMATION RECEIVED 7/27/2018: THE REP COULD NOT FIND OUT THE DATE OF THE IMPLANT REMOVAL SURGERY. SHE JUST KNEW THAT THE REMOVAL SURGERY WAS PERFORMED RECENTLY AND THE ORIGINAL IMPLANTED DATE IS (B)(6) 2016. ((B)(6) 2018 WILL BE USED AS THE EVENT DATE). ALL RELATED SCREWS HAVE BEEN ALREADY DISCARDED BY HOSPITAL; THEREFORE, PART NUMBERS COULD NOT BE OBTAINED. THE IMPLANTS WERE REMOVED BECAUSE THE BONE HAD HEALED.

  Patient problems: No Code Available

  MAUDE report 7739145 ↗
• InjuryDec 19, 2016Failure To Adhere Or Bond

  IT WAS REPORTED THAT THE PLATE WAS INSERTED FOR A HUMERAL FRACTURE AND THEN POST-OP THE BUSHING PULLED OUT WHICH CAUSED THE SCREW TO PULL OUT OF THE BONE. AS A RESULT, A REVISION SURGERY HAD TO BE PERFORMED. REVISION SURGERY WAS DONE ON (B)(6) 2016 WITH ANOTHER MANUFACTURER'S PLATE.

  Patient problems: Fracture, Arm

  MAUDE report 6184917 ↗