BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE PIP SZ. 0

    MDR report key: 8735521 · Received June 26, 2019

    Report

    Report Number
    1651501-2019-00022
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    October 11, 2018
    Report Date
    April 20, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    PMA / PMN Number
    K082231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AS SUCH, A FAILURE ANALYSIS COULD NOT BE CONDUCTED. A REVIEW OF THE LOT RECORDS WAS CONDUCTED, AND DID NOT FIND ANY INDICATION OF PROBLEMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. AS THE IMPLANT WAS NOT RETURNED FOR INVESTIGATION, A POSSIBLE ROOT CAUSE COULD NOT BE FOUND. THE REPORTED COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT THE CUSTOMER WAS UNHAPPY ABOUT THE LACK OF BACKUP SIZES FOR AN SPIP-520-0-WW SILICONE PIP IN A CASE THEY HAD DONE. ON (B)(6) 2018, THE PATIENT CAME IN FOR HAND SURGERY DUE TO JOINT ARTHRITIS: RIGHT LONG FINGER PIP JOINT AND RIGHT RING PIP JOINT ARTHROPLASTY. DURING SURGERY, THE SURGEON DECIDED TO PUT IN A SIZE #0 FOR ONE FINGER, AND THEN NEEDED THE SAME SIZE ON A SECOND FINGER. THE IMPLANT BANK THAT WAS SHIPPED TO THE FACILITY ONLY CONTAINED ONE SIZE #0. THE SURGEON DECIDED NOT TO USE A DIFFERENT SIZE AND INSTEAD CLOSED THE PATIENT AND WOULD REVISIT TO DO THE OTHER FINGER. NOW THE PATIENT WILL NEED TO GO THROUGH ANOTHER SURGERY AND POST OP THERAPY. THERE WAS NEVER A PLAN TO HAVE TO COME BACK FOR FURTHER PROCEDURES ON THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528216 SILICONE PIP SZ. 0 SILICONE PIP KYJ ASCENSION ORTHOPEDICS 174078T

    Patients

    Seq Age Sex Outcome Treatment
    1