Arthrex® AR-1400CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867016163), received between Aug 30, 2018 and Jan 6, 2026 — classified as 3 injuries, 2 malfunctions.

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

• MalfunctionJan 6, 2026Component Missing

  UPDATE 13-JAN-2026: IT WAS CONFIRMED THAT THE SURGEON ATTEMPTED TO USE THE IMPLANT BUT IT FAILED TO HOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977115 ↗
• MalfunctionDec 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 11/27/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1400C BIOCOMPOSITE INTERFERENCE SCREW HAS A DAMAGED THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383050 ↗
• InjuryNov 4, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW WAS IMPLANTED ON (B)(6) 2016 DURING AN ACL PROCEDURE INTO THE TIBIA. THE PATIENT DEVELOPED AN INFLAMMATION REACTION IN THE TIBIA AFTER THE ACL PROCEDURE. THE SCREW REMAINS IN THE PATIENT. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 10784224 ↗
• InjuryApr 9, 2019Material Rupture

  IT WAS REPORTED AFTER HAVING AN ACL RECONSTRUCTION WITH BIOCOMPOSITIE SCREW FIXATION PERFORMED ON (B)(6) 2018, THE PATIENT PROCEEDED TO HAVE CYSTIC CHANGES AROUND WHERE THE AR-1400C, BIOCOMPOSITE INTERFERENCE SCREW 10 X 23MM (LOT: 10153856) WAS IMPLANTED. THE CYSTIC CHANGES CREATED A 20MM WIRE TUNNEL, AND THE PATIENT RE-RUPTURED THEIR ACL. THERE WAS NO WIDENING AT THE APERTURE AND THE ANTERIOR CORTEX OF THE TIBIA. THE WIDENING OCCURRED ONLY IN THE MIDDLE PART OF THE TUNNEL, WHERE THE SCREW WAS PRESENT. THE FOLLOWING ARTHREX PARTS WERE USED DURING THE ORIGINAL PROCEDURE THAT TOOK PLACE ON (B)(6) 2018: AR-1204AF-95 // LOT: 735379685 // QTY.: 1; AR-1370C // LOT: 10179054 // QTY.: 1; AR-1390C // LOT: 10140550 // QTY.: 1; AR-1400C // LOT: 10153856 // QTY. 1; AR-1588TB // LOT: 10081396 // QTY.: 1; AR-1897S // LOT: 10172069 // QTY.: 1; AR-1981-08S // LOT: 734579451 // QTY.: 1; AR-4005B-18 // LOT: E1617 // QTY.: 1; AR-4005B-18 // LOT: E5955 // QTY.: 1; AR-7209SN // LOT: 18669 // QTY.: 1; AND AR-7235T // LOT: 10183941 // QTY.: 1. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 BY THE SAME SURGEON WHO PERFORMED THE ORIGINAL, AND TOOK PLACE AT A DIFFERENT FACILITY. AR-1400C (LOT: 10153856)

  Patient problems: Cyst(s)

  MAUDE report 8495906 ↗
• InjuryAug 30, 2018Break; Material Fragmentation

  IT WAS REPORTED THAT ON THE (B)(6) 2015 A REPLACEMENT OF THE CRUCIATE LIGAMENT SURGERY TOOK PLACE. THE SURGEON DID THE TRANSFIX TECHNIQUE WITH SEMITENDINOSIS TENDON AND PLACED TIBIAL THE BIOCOMPOSITE INTERFERENCE SCREW FOR FIXATION. AFTER SURGERY THE PATIENT COMPLAINT ABOUT POST-OPERATIVE PAIN (DATE OF COMPLAINT BY PATIENT UNKNOWN). THE CUSTOMER PERFORMED A MAGNETIC RESONANCE IMAGING WHICH REVEALED A BROKEN FRAGMENT OF THE SCREW WHICH IS NOT FIXED INTO THE BONE. (THE FACILITY CANT PROVIDE PICTURES OF THE MRI) THE SURGEON DECIDED ON A ARTHROSCOPIC REVISION SURGERY TO REMOVE THE BROKEN FRAGMENT. THE REVISION TOOK PLACE ON THE (B)(6) 2017.

  Patient problems: Pain

  MAUDE report 7832226 ↗