Arthrex® AR-13380-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867011557), received between Jul 3, 2023 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 (B)(6) 2024 AND WAS COMPLETED SUCCESSFULLY USING A COMPETITOR OSTEOTOMY PLATE. NO FURTHER INJURY TO PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 20024866 ↗
• 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 20011217 ↗
• 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 17247991 ↗