Arthrex® AR-13280-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867010574), received between Oct 25, 2017 and Aug 24, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT AFTER AN INITIAL HTO SURGERY ON (B)(6) 2019, IT WAS FOUND THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. THE SCREWS COULD NOT BE REMOVED DURING THE REVISION SURGERY. IT'S UNCLEAR IF THE SCREWS BROKE IN SITU OR DURING THE REVISION SURGERY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. UPDATE 12-AUG-2020: IT WAS REPORTED BY THE CUSTOMER THAT SOME PROXIMAL SCREWS WERE BROKEN. WHEN REMOVING THE PLATE AND SCREWS THEY ALL BROKE AROUND 1CM FROM SCREWHEAD. THE PLATE AND SCREWS WERE (PARTIALLY) TAKEN OUT. THE SURGEON DECIDED THAT HE NOT WANTED TO PLACE ANOTHER PLATE DUE TO PARTIAL CONSOLIDATION.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 10441885 ↗
• InjuryAug 24, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT AFTER AN INITIAL HTO SURGERY ON (B)(6) 2019, IT WAS FOUND THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. THE SCREWS COULD NOT BE REMOVED DURING THE REVISION SURGERY. IT'S UNCLEAR IF THE SCREWS BROKE IN SITU OR DURING THE REVISION SURGERY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. UPDATE 12-AUG-2020: IT WAS REPORTED BY THE CUSTOMER THAT SOME PROXIMAL SCREWS WERE BROKEN. WHEN REMOVING THE PLATE AND SCREWS THEY ALL BROKE AROUND 1CM FROM SCREWHEAD. THE PLATE AND SCREWS WERE (PARTIALLY) TAKEN OUT. THE SURGEON DECIDED THAT HE NOT WANTED TO PLACE ANOTHER PLATE DUE TO PARTIAL CONSOLIDATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10441871 ↗
• InjuryAug 18, 2020Material Fragmentation; Difficult to Remove

  IT WAS REPORTED THAT AFTER AN INITIAL HTO SURGERY ON (B)(6) 2019, IT WAS FOUND THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. THE SCREWS COULD NOT BE REMOVED DURING THE REVISION SURGERY. IT'S UNCLEAR IF THE SCREWS BROKE IN SITU OR DURING THE REVISION SURGERY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. FURTHER QUESTIONS WILL BE ASKED. UPDATE 12-AUG-2020, ASA: IT WAS REPORTED BY THE CUSTOMER THAT SOME PROXIMAL SCREWS WERE BROKEN. WHEN REMOVING THE PLATE AND SCREWS THEY ALL BROKE AROUND 1CM FROM SCREWHEAD. THE PLATE AND SCREWS WERE (PARTIALLY) TAKEN OUT. THE SURGEON DECIDED THAT HE DID NOT WANT TO PLACE ANOTHER PLATE DUE TO PARTIAL CONSOLIDATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10422393 ↗
• InjuryAug 17, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT CONTOURLOCK SCREWS BROKE INSIDE OF THE PATIENT. A PLATE WAS REMOVED BUT ON TWO SCREWS OUT OF FIVE, THE DISTAL END BROKE OFF AND REMAINS INSIDE OF THE PATIENT. AT THE MOMENT, ONLY TWO IMAGES HAVE BEEN MADE AVAILABLE, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. FURTHER QUESTIONS BEING ASKED. UPDATE 22-JUL-2020: 3 PROXIMAL SCREWS BROKE AT PROXIMATELY 1 CM AWAY FROM THE SCREW HEAD, SEE PHOTO ATTACHED. THE SURGEON COULD REMOVE 1 SCREW END. THE OTHER 2 SCREWS WERE DIFFICULT TO REMOVE BECAUSE LARGER HOLES WILL WEAKEN THE TIBIA PLATEAU. THE BROKEN INSTRUMENT VISIBLE ON THE IMAGE ON THE TABLE WAS SOME KIND OF A CORING REAMER/ REMOVAL TOOL BUT IS NOT AN ARTHREX DEVICE. PART, LOT NUMBERS, POST OP X-RAYS AND DATE OF INITIAL SURGERY WAS REQUESTED AS WELL FROM THE SALES REP TO THE SURGEON. UPDATE 05-AUG-2020: INFORMATION RECEIVED THAT THE FOLLOWING SCREWS ARE DEFECT AND WILL BE RETURNED: AR-13280-50 / LOT:10198579. AR-13280-55 / LOT:10184902. AR-13280-55 / LOT: 10208687. NO MORE INFORMATION NOR X-RAYS ARE AVAILABLE FROM THE HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10416955 ↗
• InjuryAug 17, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT CONTOURLOCK SCREWS BROKE INSIDE OF THE PATIENT. A PLATE WAS REMOVED BUT ON TWO SCREWS OUT OF FIVE, THE DISTAL END BROKE OFF AND REMAINS INSIDE OF THE PATIENT. AT THE MOMENT, ONLY TWO IMAGES HAVE BEEN MADE AVAILABLE, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. FURTHER QUESTIONS BEING ASKED. UPDATE 22-JUL-2020: 3 PROXIMAL SCREWS BROKE AT PROXIMATELY 1 CM AWAY FROM THE SCREW HEAD. THE SURGEON COULD REMOVE 1 SCREW END. THE OTHER 2 SCREWS WERE DIFFICULT TO REMOVE BECAUSE LARGER HOLES WILL WEAKEN THE TIBIA PLATEAU. THE BROKEN INSTRUMENT VISIBLE ON THE IMAGE ON THE TABLE WAS SOME KIND OF A CORING REAMER/ REMOVAL TOOL BUT IS NOT AN ARTHREX DEVICE. PART, LOT NUMBERS, POST OP X-RAYS AND DATE OF INITIAL SURGERY WAS REQUESTED AS WELL FROM THE SALES REP TO THE SURGEON. UPDATE 05-AUG-2020: INFORMATION RECEIVED THAT THE FOLLOWING SCREWS ARE DEFECT AND WILL BE RETURNED: AR-13280-50 / LOT:10198579. AR-13280-55 / LOT:10184902. AR-13280-55 / LOT: 10208687. NO MORE INFORMATION NOR X-RAYS ARE AVAILABLE FROM THE HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10416857 ↗
• InjuryOct 25, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A DISTAL FEMORAL OSTEOTOMY PROCEDURE WHERE THE FOLLOWING DEVICES WERE IMPLANTED: CORTICAL SCREW, AR-13380-34 (LOT: 10140529, LINE 208645), AR-13110R-01 (LOT: 10129525, LINE 210798), AR-13370-1 (LOT: M16906P016, LINE 210799), AR-13370-2 (LOT: M16914C015, LINE 210800), AR-13280-55 (LOT: 10122391, LINE 210801), AR-13380-44 (LOT: 10124044, LINE 210802) AR-13380-46, (LOT: 10084866, LINE 210803), AR-13380-38 (LOT: 10136981, LINE 210804), AND, AR-13880-36 (LOT: 10136979, LINE 210805) INTO THE PATIENT'S FEMUR. DURING THE PROCEDURE, AN AP X-RAY WAS TAKEN WITH NO INDICATIONS OF ANY ABNORMALITIES. ON (B)(6) 2017, THE PATIENT CAME IN FOR A POST-OP CHECK-UP WHERE A LATERAL X-RAY WAS TAKEN SHOWING A FRACTURE IN THE PATIENT'S FEMUR. THE PATIENT HAS NOT EXPERIENCED ANY PAIN OR DISCOMFORT. THE SURGEON IS GOING TO KEEP THE PATIENT NON-WEIGHT BEARING FOR A FEW MORE WEEKS. PATIENT IS A FEMALE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6975634 ↗