Arthrex® AR-13380-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867011588), received between Jul 19, 2017 and Jul 15, 2024 — classified as 8 injuries, 2 malfunctions.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2024Break; Break

  ON 04/24/2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT AFTER UNDERGOING A DISTAL FEMUR OSTEOTOMY ON (B)(6) 2023 ONE OF THE SIX IMPLANTED SCREWS BROKE. THIS WAS DISCOVERED 3 1/2 MONTHS POST-OP IN AN X-RAY. ON (B)(6) 2023, WHEN THIS PROCEDURE TOOK PLACE, AN AR-13280-60 CANCELLOUS SCREW, AN AR-13380-54 CORTICAL SCREW, AN AR-13280-60 CANCELLOUS SCREW, AN AR-13380-50 CORTICAL SCREW, AN AR-13280-65 CANCELLOUS SCREW, AND AN AR-13380-46 CANCELLOUS SCREW WERE IMPLANTED. IT HAS NOT BEEN CONFIRMED WHICH SCREW BROKE. A POST-OP X-RAY WAS TAKEN 2 MONTHS POST-OP WHERE EVERYTHING LOOKED GOOD; HOWEVER, THE X-RAY TAKEN 3 1/2 MONTHS POST SHOWED A BROKEN SCREW THAT HAD PARTIALLY MADE ITS WAY. THE INTEGRITY OF THE HEALING BONE WILL DETERMINE WHEN A REVISION WILL BE TAKING PLACE. ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT WHERE HE STATED THAT A TEST HAD BEEN RUN TO CONFIRM THERE WERE NO DEFICIENCIES WITH HIS HEALTH THAT WOULD CAUSE THIS FAILURE. THE PATIENT WILL BE UNDERGOING A REVISION SURGERY WITH A TRAUMA SURGEON. THERE PATIENT STATED HIS FEMUR IS NOW SHORT ON BOTH SIDES DUE TO THE BREAKAGE. ADDITIONAL INFORMATION WAS PROVIDED ON 06/27/2024, WHERE THE PATIENT REPORTED THAT A REVISION PROC

  Patient problems: Failure of Implant

  MAUDE report 19740517 ↗
• MalfunctionMay 3, 2024Defective Device; Defective Device

  IT WAS REPORTED ON 09/12/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13200ST-07.5 OSTEOTOMY PLATE BUSHING POPPED OFF AND THE SURGEON WAS UNABLE TO USE THE AR-13380-46 SCREW IN THE PROCEDURE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237811 ↗
• MalfunctionApr 26, 2024Defective Device; Defective Device

  ON 09/12/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT THE BUSHING OF AN AR-13200ST-07.5 PLATE POPPED OFF WHEN AN AR-13380-46 CORTICAL SCREW WAS BEING INSERTED. THE SCREW WAS NOT ABLE TO BE USED AND A LARGER SCREW WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195368 ↗
• InjuryJul 3, 2023Break; Break

  ON 6/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW BROKE POST-OPERATIVE. THIS WAS DISCOVERED DURING A POST-OPERATION FOLLOW-UP X-RAY ON (B)(6) 2023. THE PATIENT HAS COMPLAINED OF A SENSATION OF INSTABILITY BUT DOES NOT REPORT A SPECIFIC EVENT OR TIME FRAME IN WHICH THE INSTABILITY STARTED. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT OCCURRED YET. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2022, AND REVISION SURGERY OCCURRED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: DURING THE REVISION SURGERY, AN ABS-3016 SYNTHETIC BONE FILLER, AN AR-13200ST-17.5 TIBIAL A/P SLOPED OSTEOTOMY PLATE, THREE AR-13370-4 OSFERION OSTEOTOMY WEDGE, AN AR-13380-40 CORTICAL SCREW, AND AN AR-13380-46 CORTICAL SCREW WERE EXPLANTED ALONG WITH THE BROKEN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 17248047 ↗
• InjuryDec 15, 2017Appropriate Device Problem Term/Code Not Available

  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: Bone Fracture(s)

  MAUDE report 7120778 ↗
• 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 7120776 ↗
• 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 Code Available

  MAUDE report 7005828 ↗
• 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 7005821 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information

  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 6975637 ↗
• InjuryJul 19, 2017Fracture

  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: No Known Impact Or Consequence To Patient

  MAUDE report 6725300 ↗