Arthrex® AR-13280-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867010567), received between Jul 22, 2020 and Jul 3, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Break; Break

  ON 6/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL, THAT AN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW BROKE POST-OPERATIVE. THIS WAS DISCOVERED DURING A POST-OPERATION FOLLOW-UP X-RAY ON (B)(6) 2023. THE PATIENT HAS COMPLAINED OF A SENSATION OF INSTABILITY, BUT DOES NOT REPORT A SPECIFIC EVENT OR TIME FRAME IN WHICH THE INSTABILITY STARTED. THE IMPLANTS ARE STILL IN THE PATIENT. AND REVISION SURGERY HAS NOT OCCURRED YET. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2022. AND REVISION SURGERY OCCURRED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: DURING THE REVISION SURGERY, AN ABS-3016 SYNTHETIC BONE FILLER, AN AR-13200ST-17.5 TIBIAL A/P SLOPED OSTEOTOMY PLATE, THREE AR-13370-4 OSFERION OSTEOTOMY WEDGE, AN AR-13380-40 CORTICAL SCREW, AND AN AR-13380-46 CORTICAL SCREW WERE EXPLANTED. ALONG WITH THE BROKEN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY. AND BY THE SAME SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 17247894 ↗
• 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 10441864 ↗
• 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 10422347 ↗
• InjuryAug 18, 2020Break; 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 AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. FURTHER QUESTIONS WILL BE ASKED 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 DID NOT WANT TO PLACE ANOTHER PLATE DUE TO PARTIAL CONSOLIDATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10422043 ↗
• InjuryAug 18, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. UPDATE 17-AUG-2020: DURING A REMOVAL SURGERY THE HEAD OF THE SCREWS BROKE OFF AT THE PROXIMAL END. THE DISTAL PART OF THE SCREWS COULD NOT BE REMOVED AND WILL BE LEFT INSIDE OF THE PATIENT. THE PLATE AND THE HEAD OF THE SCREWS WERE REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10421487 ↗
• InjuryAug 18, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. UPDATE 17-AUG-2020: DURING A REMOVAL SURGERY THE HEAD OF THE SCREWS BROKE OFF AT THE PROXIMAL END. THE DISTAL PART OF THE SCREWS COULD NOT BE REMOVED AND WILL BE LEFT INSIDE OF THE PATIENT. THE PLATE AND THE HEAD OF THE SCREWS WERE REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10421470 ↗
• InjuryAug 18, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. UPDATE 17-AUG-2020: DURING A REMOVAL SURGERY THE HEAD OF THE SCREWS BROKE OFF AT THE PROXIMAL END. THE DISTAL PART OF THE SCREWS COULD NOT BE REMOVED AND WILL BE LEFT INSIDE OF THE PATIENT. THE PLATE AND THE HEAD OF THE SCREWS WERE REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10421437 ↗
• InjuryAug 18, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. UPDATE 17-AUG-2020: DURING A REMOVAL SURGERY THE HEAD OF THE SCREWS BROKE OFF AT THE PROXIMAL END. THE DISTAL PART OF THE SCREWS COULD NOT BE REMOVED AND WILL BE LEFT INSIDE OF THE PATIENT. THE PLATE AND THE HEAD OF THE SCREWS WERE REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10421407 ↗
• InjuryAug 17, 2020Break

  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 10416748 ↗
• InjuryJul 22, 2020Break

  IT WAS REPORTED THAT AFTER AN INITIAL SUCCESSFUL SURGERY WHICH WAS PERFORMED ON (B)(6)2019 A PATIENT COMPLAINT ABOUT PAIN NEARBY THE OSTEOTOMY. A CT AND X-RAY WAS PERFORMED AND CONFIRMED THAT THE SCREW HEADS WERE OUT OF THE PLATE AND THEREFORE FOUND TO BE BROKEN. A REVISION HIGH TIBIAL OSTEOTOMY WAS SUCCESSFULLY PERFORMED ON (B)(6) 2020 TO RETRIEVE THE SCREWS OUT OF THE PATIENT. UPDATE 27-JUL-2020: FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON TOOK OUT OF THE PLATE AND DID NOT IMPLANTED A NEW ONE AS HE THOUGHT THE (PARTIAL) CONSOLIDATION WAS ALREADY THERE.

  Patient problems: Pain

  MAUDE report 10307910 ↗