PERCANNULA 222274Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705020263), received between Sep 24, 2018 and Sep 24, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2018Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN THE (B)(6) THAT DURING A PARTIAL CUFF TEAR REPAIR, THE WHEN INSERTING THE ANCHOR HALF WAY INTO THE BONE, IT LOOKED LIKE THE ANCHOR BROKE. BUT THE OUTER SHAFT OF THE PERCANULE SYSTEM SHOW A DENT ON ONE SITE. WHICH MAY LEAD TO THINK IT CUT THE ANCHOR OFF. YOU CAN ALSO SEE THAT ON THE EDGE WERE THE ANCHOR BROKE OF/ HAS BEEN CUT OFF. LUCKILY THE PART OF THE ANCHOR WHICH GOT INTO THE BONE, HELD AND SO THE DOCTOR COULD FINISH THE REPAIR. IT WAS REPORTED THAT THE PROXIMAL PART WAS BEING SENT BACK (WITH CORTICAL TREADS) AS THE DISTAL PART WITH THE SUTURES REMAINED IN THE PATIENT. IT WAS REPORTED THAT THE ANCHOR SEEMED TO BE CUT OFF (BY THE OUTER SHAFT OF THE PERCANULA SYSTEM) BETWEEN THE CORTICAL AND CANCELLOUS TREADS. THE SURGEON WAS SATISFIED ENOUGH TO FINISH THE PROCEDURE WITH IT AND WITH THE REMAINING DISTAL PART OF THE ANCHOR, CAUSE IT STILL HAD SOME FIXATION THIS FAILURE DID NOT EXTEND THE PROCEDURE TIME GREATER THAN 30 MINUTES BECAUSE HE FINISHED THE PROCEDURE WITH THE FIRST ANCHOR (WHICH PARTIALLY REMAINED IN THE PATIENTS BONE). THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901741 ↗