Arthrex® AR-13280-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867010604), received between Nov 7, 2017 and Jan 23, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Crack” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2019Patient-Device Incompatibility

  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 8270506 ↗
• InjuryJan 23, 2019Incorrect, Inadequate or Imprecise Result or Readings

  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 8270486 ↗
• 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 Known Impact Or Consequence To Patient

  MAUDE report 7120777 ↗
• InjuryNov 7, 2017Crack

  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 Code Available

  MAUDE report 7005829 ↗
• InjuryNov 7, 2017Crack

  IT WAS REPORTED THAT THE DFO (DISTAL FEMORAL OSTEOTOMY) PROCEDURE WENT WELL , GOOD ALIGNMENT 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 ((B)(4) LINE 209692), AR-13280-70 LOT 10076262 ((B)(4) LINE 210847), AR-13380-42 LOT 10081230 ((B)(4) LINE 210849), AR-13380-46 LOT 10084866 ((B)(4) LINE 210851), AR-13380-56 LOT 1142998 ((B)(4) LINE 210852) AND AR-13380-50 LOT 10081367 ((B)(4) LINE 210854).

  Patient problems: No Code Available

  MAUDE report 7005817 ↗