Arthrex® AR-1351C-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867013704), received between Jan 13, 2020 and Jan 5, 2021 — classified as 3 injuries.

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 18, 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.

• InjuryJan 5, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY WHEN HITTING IN, ABOUT HALF OF THE IMPLANT BROKE INTO MANY PIECES. THE REST OF BROKEN SCREW WAS LEFT IN PATIENT. UPDATE 22-DEC-2020: THE BROKEN PART OF SCREW HAS NOT BEEN REMOVED FROM PATIENT, BECAUSE IT WOULD HAVE BEEN NECESSARY TO DRILL IT OUT. BUT THE BROKEN SCREW DOESN¿T FULFILL ITS FUNCTION. THE OTHER BROKEN PIECES OF THE SCREW WERE ALL FLUSHED OUT. INITIALLY IT WAS PLANNED A TRANSFIX TECHNIQUE, WHICH FIXES FROM THE LATERAL SIDE. DUE TO THE BREAKAGE IT WAS CHANGED TO FIX IT THROUGH THE ANTEROMEDIAL PORTAL, WHICH HAS AN EFFECT ON THE TEARING FORCES. AN AR-4030C-08 WAS USED TO FINISH THE SURGERY SUCCESSFULLY. A SECOND SURGERY WAS NOT NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11120065 ↗
• InjurySep 17, 2020Material Split, Cut or Torn

  AN ARTHREX EMPLOYEE HAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WITH TRANSFIX PIN, WHILE HAMMERING IN THE PIN, THE HEAD WAS TORN AND SPLIT INTO 2 HALVES. THE SURGEON WAS NOT ABLE TO RETRIEVE THE PART OUT OF THE PATIENT AND HAD TO SWITCH TO A DIFFERENT TECHNIQUE. THE SURGEON USED A SCREW TO FINISH THE SURGERY SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10546363 ↗
• InjuryJan 13, 2020Break

  IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT SURGERY THE COMPOSITE MATERIAL HAS BROKEN-OFF PROXIMALLY DURING INSERTION. THE PART WHICH BROKE OFF REMAINED IN THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9582749 ↗