Arthrex® AR-13380-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867011564), received between Nov 7, 2017 and Jul 3, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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. 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 4 most recent of 4 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 (2) AR-13380-42 CORTICAL SCREWS WERE FOUND BROKEN DURING A POST-OPERATIVE FOLLOW-UP. THE PROCEDURE WAS A HIGH TIBIAL OSTEOTOMY. THE PATIENT DID NOT HAVE ANY SIGNIFICANT COMPLAINTS AND DID NOT RECALL AN EVENT OR INJURY TO HAVE OCCURRED. A COLLAPSE WAS NOTICED IN THE PATIENT'S OSTEOTOMY SITE. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT HAPPENED YET. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6)2023, AND REVISION SURGERY OCCURRED ON (B)(6)2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: DURING THE REVISION SURGERY, AN AR-13200T-12.5 TIBIAL OPENING WEDGE OSTEOTOMY PLATE, TWO AR-13280-45 CANCELLOUS SCREW, AND THREE AR-13370-3 OSFERION OSTEOTOMY WEDGE WERE EXPLANTED ALONG WITH THE TWO BROKEN AR-13380-42 CORTICAL SCREWS. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

  Patient problems: Failure of Implant

  MAUDE report 17246975 ↗
• InjuryJul 3, 2023Break; Break

  ON 6/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-13380-42 CORTICAL SCREWS WERE FOUND BROKEN DURING A POST-OPERATIVE FOLLOW-UP. THE PROCEDURE WAS A HIGH TIBIAL OSTEOTOMY. THE PATIENT DID NOT HAVE ANY SIGNIFICANT COMPLAINTS AND DID NOT RECALL AN EVENT OR INJURY TO HAVE OCCURRED. A COLLAPSE WAS NOTICED IN THE PATIENT'S OSTEOTOMY SITE. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT HAPPENED YET. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2023, AND REVISION SURGERY OCCURRED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: DURING THE REVISION SURGERY, AN AR-13200T-12.5 TIBIAL OPENING WEDGE OSTEOTOMY PLATE, TWO AR-13280-45 CANCELLOUS SCREW, AND THREE AR-13370-3 OSFERION OSTEOTOMY WEDGE WERE EXPLANTED ALONG WITH THE TWO BROKEN AR-13380-42 CORTICAL SCREWS. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

  Patient problems: Failure of Implant

  MAUDE report 17246890 ↗
• InjuryJan 23, 2019Fracture

  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 8270478 ↗
• InjuryNov 7, 2017Crack

  IT WAS REPORTED THAT THE DFO (DISTAL FEMORAL OSTEOTOMY) PROCEDURE WENT WELL , GOOD ALIGNEMENT OF THE PLATE. ALL SCREWS WERE DRILLED WITH AR-13319. A CRACK WAS HEARD DURING THE FIXATION OF THE CORTICAL SCREWS. A FISSURE IS VISIBLE IN THE POST OP X-RAY. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE: AR-13110R-01 LOT 1142477 (CC127085 LINE 209692), AR-13280-70 LOT 10076262 (CC127085 LINE 210847), AR-13380-42 LOT 10081230 (CC127085 LINE 210849), AR-13380-46 LOT 10084866 (CC127085 LINE 210851), AR-13380-56 LOT 1142998 (CC127085 LINE 210852) AND AR-13380-50 LOT 10081367 (CC127085 LINE 210854).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005813 ↗