BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE PIP SZ. 2

    MDR report key: 7370698 · Received March 26, 2018

    Report

    Report Number
    1651501-2018-00022
    Event Type
    Injury
    Date Received
    March 26, 2018
    Report Date
    March 15, 2018
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    PMA / PMN Number
    K082231
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. REVIEW OF MANUFACTURING RECORDS SHOWED NO EVIDENCE OF A NONCONFORMANCE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION RECEIVED TO DATE, THE ROOT CAUSE CANNOT BE DETERMINED NOR CAN THE FAILURE BE CONFIRMED. THE INITIAL REPORT STATES THAT THE PATIENT WAS FLICKING A BOOK PAGE, AND THE RELATIONSHIP OF THIS EVENT TO THE BREAK CANNOT BE DETERMINED. OUTSIDE OF PATIENT TRAUMA, AN IMPROPERLY SEATED IMPLANT LEADING TO ADDITIONAL STRESS ON THE HINGE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO ILS-AUSTIN. AS RECEIVED, THE DEVICE WAS OBSERVED TO BE IN TWO SEPARATE PIECES, CONFIRMING THE FAILURE. BASED ON THE INFORMATION AND FAILURE ANALYSIS RECEIVED TO DATE, THE FAILURE IS CONFIRMED. HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO ILS-AUSTIN. AS RECEIVED, THE DEVICE WAS OBSERVED TO BE IN TWO SEPARATE PIECES, CONFIRMING THE FAILURE. ADDITIONAL ANALYSIS WAS LATER PERFORMED. VISUAL EXAMINATION AIDED WITH A STEREOMICROSCOPE REVEALED A TEAR ACROSS THE WEB IN THE IMPLANT HINGE. FRACTURE TOPOGRAPHY INDICATED A BENDING OVERLOAD TEAR FRACTURE. THE WEB TEAR IS CONSISTENT WITH BENDING OVERLOAD. ALSO, THE WEB OF THE HINGE HAS THE SMALLEST CROSS SECTION AND IS THE TYPICAL LOCATION OF FAILURES IN THE SILICONE IMPLANTS. BASED ON THE INFORMATION AND FAILURE ANALYSIS RECEIVED TO DATE, THE FAILURE IS CONFIRMED. HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED. THE INITIAL REPORT STATES THAT THE PATIENT WAS FLICKING A BOOK PAGE, AND THE RELATIONSHIP OF THIS EVENT TO THE BREAK CANNOT BE DETERMINED. OUTSIDE OF PATIENT TRAUMA, AN IMPROPERLY SEATED IMPLANT LEADING TO ADDITIONAL STRESS ON THE HINGE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPIP-520-2-WW SILICONE PIP IMPLANT BROKE. IN (B)(6) 2016, A PIP J REPLACEMENT IN THE INDEX FINGER WAS PERFORMED WITH A SPIP-520-2-WW SILICONE PIP IMPLANT. IN (B)(6) 2018, 17 MONTHS POST IMPLANTATION, THE IMPLANT BROKE WHILE THE PATIENT WAS FLICKING THE PAGE OF A BOOK. NO SPECIFIC TRAUMA OR CONTRIBUTING EVENTS PRIOR TO THE DISCOVERY OF THE ISSUE. SUBSEQUENTLY, THE IMPLANTED PRODUCT WAS EXPLANTED AND WAS REPLACED WITH ANOTHER OF THE SAME SIZE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214126 SILICONE PIP SZ. 2 SILICONE PIP KYJ ASCENSION ORTHOPEDICS 151016T

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention