Arthrex® AR-13380-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867011540), received between Oct 25, 2017 and Aug 22, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13110L-01 OSTEOTOMY PLATE ALL SCREWS BACKED OUT AND THE PLATE COLLAPSED. THIS OCCURRED AFTER USE IN A CASE AND THE PATIENT REQUIRES A REVISION. THE REVISION SURGERY WAS SCHEDULED FOR 7/9/24 AND WAS COMPLETED SUCCESSFULLY USING A COMPETITOR OSTEOTOMY PLATE. NO FURTHER INJURY TO PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 20029874 ↗
• InjuryAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13110L-01 OSTEOTOMY PLATE ALL SCREWS BACKED OUT AND THE PLATE COLLAPSED. THIS OCCURRED AFTER USE IN A CASE AND THE PATIENT REQUIRES A REVISION. THE REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2024 AND WAS COMPLETED SUCCESSFULLY USING A COMPETITOR OSTEOTOMY PLATE. NO FURTHER INJURY TO PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 20023471 ↗
• 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 6975632 ↗