Arthrex® AR-13380-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867011571), received between Oct 25, 2017 and Jan 23, 2019 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 18, 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.

• InjuryJan 23, 2019Break

  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 8272099 ↗
• InjuryNov 19, 2018Break

  IT WAS REPORTED THAT THE PATIENT INITIALLY HAD A PROCEDURE ON (B)(6) 2017. IT WAS ALSO REPORTED THAT THERE WERE TWO SCREWS WHICH HAD BROKEN POST OPERATIVELY WHICH CAUSED A DELAY IN THE BONE CONSOLIDATION. A SECOND SURGERY WAS PERFORMED. THE PART NUMBER OF THE SCREWS WERE AR-13380-XX HOWEVER THE EXACT SIZE (XX) WAS NOT PROVIDED AT TIME OF REPORT. THE SCREWS WERE REPORTED TO HAVE BEEN DISCARDED. THE TYPE OF PROCEDURE INITIALLY PERFORMED ON (B)(6) 2017 AND THE DATE OF THE SECOND SURGERY WERE NOT PROVIDED AT TIME OF INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPDATE 06-DEC-2018: PER ARTHREX FRANCE THE PART NUMBER THAT WERE REMOVED ARE AR-13380-40 & AR-13380-44. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8084131 ↗
• InjuryMar 23, 2018Fracture

  IT WAS REPORTED THAT DURING A DISTAL FEMORAL OSTEOTOMY PROCEDURE, AS THE SURGEON WAS TIGHTENING THE SECOND CORTICAL SCREW, AR-13380-44 (LOT: 10130957, (B)(4)) INTO THE CONTOURLOCK FEMORAL OSTEOTOMY PLATE, AR-13110L-02 (LOT: 10162249, (B)(4)), THE LATERAL CORTEX OF THE FEMUR BECAME FRACTURED. THE SURGEON WENT ON TO INSERT THE REMAINING SCREWS (LISTED BELOW) AND THEN OPENED UP A DIFFERENT MANUFACTURER'S DEVICE TO HOLD THE FRACTURE AND THE PLATE TOGETHER TO PROVIDE SUPPORT SO THAT THE FRACTURE DID NOT SPREAD. A FLUORO WAS TAKEN DURING THE CASE TO CONFIRM THE FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365039 ↗
• InjuryDec 15, 2017Fracture

  IT WAS REPORTED THAT DURING A DISTAL FEMORAL OSTEOTOMY PROCEDURE, AS THE SURGEON INSERTED THE LAST SCREW ON THE CONTOURLOCK OSTEO PLATE (AR-13110L-02, LOT: 10156990), A PROXIMAL VERTICAL FRACTURE OCCURRED IN THE PATIENT'S LEFT FEMUR. THE SURGEON WRAPPED TWO STRYKER CABLES AROUND THE FEMUR TO SECURE THE FRACTURE AND THE CASE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THERE HAVE BEEN NO REPORTS OF COMPLICATIONS SINCE THE SURGERY. IT IS UNKNOWN WHICH SCREW WAS BEING INSERTED AT THE TIME THE FRACTURE OCCURRED. THE FOLLOWING SCREWS WERE IMPLANTED ALONG WITH THE PLATE: AR-13280-70, LOT: 10111026 / (B)(4). AR-13380-46, LOT: 10084866 / (B)(4). AR-13380-46, LOT: 10137003 / (B)(4). AR-13380-44, LOT: 10140533 / (B)(4). AR-13380-44, LOT: 10130957 / (B)(4).

  Patient problems: No Code Available

  MAUDE report 7120786 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DISTAL FEMORAL OSTEOTOMY PROCEDURE, AS THE SURGEON INSERTED THE LAST SCREW ON THE CONTOURLOCK OSTEO PLATE ((B)(4), LOT: 10156990), A PROXIMAL VERTICAL FRACTURE OCCURRED IN THE PATIENT'S LEFT FEMUR. THE SURGEON WRAPPED TWO STRYKER CABLES AROUND THE FEMUR TO SECURE THE FRACTURE AND THE CASE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THERE HAVE BEEN NO REPORTS OF COMPLICATIONS SINCE THE SURGERY. IT IS UNKNOWN WHICH SCREW WAS BEING INSERTED AT THE TIME THE FRACTURE OCCURRED. THE FOLLOWING SCREWS WERE IMPLANTED ALONG WITH THE PLATE:(B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7120781 ↗
• InjuryOct 25, 2017Fracture

  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, (B)(4)), AR-13110R-01 (LOT: 10129525, (B)(4)), AR-13370-1 (LOT: M16906P016, (B)(4)), AR-13370-2 (LOT: M16914C015, (B)(4)), AR-13280-55 (LOT: 10122391, (B)(4)), AR-13380-44 (LOT: 10124044, (B)(4)) AR-13380-46, (LOT: 10084866, (B)(4)), AR-13380-38 (LOT: 10136981, (B)(4)), AND, AR-13880-36 (LOT: 10136979, (B)(4)) 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 6975635 ↗