BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIP SZ. 10 PROXIMAL

    MDR report key: 8066147 · Received November 13, 2018

    Report

    Report Number
    1651501-2018-00059
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 18, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE DHR FOR PART NUMBER PIP-200-10P-WW (PIP SZ. 10 PROXIMAL), LOT 14-2653 WAS REVIEWED. REVIEW OF MANUFACTURING RECORDS FOR THE LOT SHOWED NO EVIDENCE OF A NONCONFORMANCE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HAS NOT BEEN RETURNED TO INTEGRA FOR EVALUATION. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PRODUCT WILL BE RETURNED. IF THE PRODUCT IS RETURNED, THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. WHILE THE ROOT CAUSE IS UNKNOWN FOR THIS CASE, SIMILAR ISSUES THAT RESULTED IN INTRA-OPERATIVE PIP FRACTURES HAVE BEEN ATTRIBUTED TO IMPROPERLY PREPARED OBLIQUE OSTEOTOMY, IMPROPER PLACEMENT OF THE IMPLANT (E.G., IMPACTING UNSUPPORTED HEAD WITH TOO MUCH FORCE), OR IMPROPER IMPLANT SIZE SELECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BROKE DURING INSERTION; THE HEAD OF THE IMPLANT WAS DETACHED FROM THE STEM. THE REASON FOR SURGERY WAS DUE TO A RIGHT HAND FRACTURE WITH RADIUS RIGIDITY. THE MEDICAL STAFF WAS ABLE TO REMOVE THE BROKEN PART INSIDE THE DIAPHYSIS DURING THE PROCEDURE WITH A K-WIRE, AND THE REMOVAL GENERATED MICRO PARTICLES. IT WAS REPLACED FOR ANOTHER SAME SIZE IMPLANT. THE EVENT LEAD TO 30-40 MINUTES SURGICAL DELAY WITH NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903286 PIP SZ. 10 PROXIMAL PIP NEG ASCENSION ORTHOPEDICS 14-2653

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR