Arthrex® AR-13380-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867011595), received between Nov 7, 2017 and Aug 21, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13110L-01 OSTEOTOMY PLATE ALL SCREWS BACKED OUT AND THE PLATE COLLAPSED. THIS OCCURRED AFTER USE IN A CASE AND THE PATIENT REQUIRES A REVISION. THE REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2024 AND WAS COMPLETED SUCCESSFULLY USING A COMPETITOR OSTEOTOMY PLATE. NO FURTHER INJURY TO PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 20010643 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DISTAL FEMORAL OSTEOTOMY PROCEDURE AS THE SURGEON WAS PUTTING IN THE LAST AR-13380-42, CORTICAL SCREW INTO THE PROXIMAL PORTION OF THE AR-13110L-02, CONTOURLOCK FEMORAL OSTEOTOMY PLATE THE SURGEON REALIZED THAT THEY NO LONGER HAD ANY PURCHASE WITH THE SCREWS IN THE PROXIMAL PORTION OF THE PLATE. UPON REMOVAL OF THE AR-13380-42 (LOT: 10166833), THE SURGEON DISCOVERED THAT THE FEMUR HAD FRACTURED UNDERNEATH THE AR-13110L-02 FROM THE OSTEOTOMY SITE ALL THE WAY TO ABOUT 7 CM PROXIMAL TO THE PLATE. THE AR-13380-42 WAS TAKEN OUT AND IMPLANTED INTO A MORE PROXIMAL HOLE. THE CASE WAS COMPLETED BY OPENING UP A LARGE FRAG SCREW SYSTEM FROM ANOTHER VENDOR, AND STABILIZING THE FRACTURE WITH TWO SEPARATE 4.5 MM LAG SCREWS. THE REP STATED THAT THE FRACTURE HAPPENED DIRECTLY UNDER THE PLATE ON THE LATERAL CORTEX ONLY. THERE WAS GOOD PURCHASE WITH ALL OF THE SCREWS ON THE MEDIAL CORTEX. THAT IN COMBINATION WITH THE DISTAL SCREWS STILL HAVING GOOD PURCHASE, THE SURGEON FELT CONFIDENT IN LEAVING THE PLATE IMPLANTED ONCE THE LAG SCREWS WERE USED TO REDUCE AND STABILIZE THE FRACTURE. THE END RESULT WAS A STABLE CONSTRUCT AND THE SURGEON DECIDED TO CLOSE WITHOUT ANY FURTHE

  Patient problems: Bone Fracture(s)

  MAUDE report 8272086 ↗
• InjuryNov 7, 2017Crack; Noise, Audible

  IT WAS REPORTED THAT THE DFO (DISTAL FEMORAL OSTEOTOMY) PROCEDURE AND SCREW DRILLING WENT WELL. GOOD ALIGNMENT OF THE PLATE. A CRACK WAS HEARD DURING THE FIXATION OF THE CORTICAL SCREWS. A FISSURE IN THE BONE WAS OBSERVED AT POST-OP RX. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE: AR-13110R-02 LOT 1478185 (CC127086 LINE 209696), AR-13280-35 LOT 1216262 (CC127086 LINE 210835), AR-13380-46 LOT 10129095 (CC127086 LINE 210838), AR-13280-45 LOT 10105613 (CC127086 LINE 210839), AR-13380-48 LOT 10073031 (CC127086 LINE 210841), AR-13380-52 LOT 10105330 (CC127086 LINE 210842), AR-13380-56 LOT 10123181 (CC127086 LINE 210844) AND AR-13280-70 LOT 10073626 (CC127086 LINE 210845).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005823 ↗