Arthrex® AR-13380-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867011533), received between Jul 19, 2017 and Oct 25, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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, LINE 208645), AR-13110R-01 (LOT: 10129525, LINE 210798), AR-13370-1 (LOT: M16906P016, LINE 210799), AR-13370-2 (LOT: M16914C015, LINE 210800), AR-13280-55 (LOT: 10122391, LINE 210801), AR-13380-44 (LOT: 10124044, LINE 210802) AR-13380-46, (LOT: 10084866, LINE 210803), AR-13380-38 (LOT: 10136981, LINE 210804), AND, AR-13880-36 (LOT: 10136979, LINE 210805) 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 6975631 ↗
• InjuryJul 19, 2017Device Damaged by Another Device

  IT WAS REPORTED THAT THE FIRST SCREW ((B)(4)) CAUSED A VERTICAL FRACTURE OF THE FEMUR. A TOTAL OF 7 SCREWS WERE USED; THE FRACTURE GOT LONGER WITH EACH SCREW. THE CASE WAS FINISHED AND CERCLAGE WIRE WAS USED TO HOLD THE FEMUR TOGETHER. FEMORAL OSTEOTOMY. NO ADDITIONAL HOSPITALIZATION WAS NEEDED. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT DURING A FEMORAL OSTEOTOMY CASE THE CONTOURLOCK FEMORAL OSTEO SMALL RIGHT PLATE, AR-13110R-01 ((B)(4)) WAS USED. WHEN IMPLANTING THE FIRST CORTICAL SCREW, AR-13380-54 ((B)(4)) IN THE MOST DISTAL OF THE PROXIMAL HOLES THE FEMUR BEGAN TO FRACTURE. THE FRACTURE CONTINUED AS THE SCREWS WERE IMPLANTED DISTAL TO PROXIMAL. THE SCREWS WERE IMPLANTED AS FOLLOWS: AR-13380-50 ((B)(4)), AR-13380-46 ((B)(4)) AND AR-13380-36 ((B)(4)). THE CASE WAS COMPLETED USING ANOTHER MANUFACTURE'S 18 GAUGE WIRE (QTY. 2) TO SECURE THE FRACTURE IN CERCLAGE TECHNIQUE. AT THIS TIME THE PATIENT HAS NOT HAD A POST OP RECHECK. PATIENT IS MALE, (B)(6). NO ADDITIONAL HOSPITALIZATION WAS NEEDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 6725313 ↗