BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 HOLE PIN CLAMP HOFFMANN II

    MDR report key: 1670571 · Received April 27, 2010

    Report

    Report Number
    8031020-2010-00048
    Event Type
    Malfunction
    Date Received
    April 27, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 6, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JEC
    PMA / PMN Number
    K952730
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAME PT EVENT AS MDR 8031020-2010-00047.

    Description of Event or Problem · 1

    EVENT AS REPORTED BY ORTHOPAEDIC TECHNICIAN: THE SURGEON WAS APPLYING BI-LATERAL TIBIAL (B)(4) EXTERNAL FIXATION USING 5MM APEX PINS AND MULTI-HOLE PIN CLAMPS. THE FIRST BLUE CLAMP (B)(4) WAS APPLIED TO 2 PINS AND TIGHTENED USING THE T-HANDLE WRENCH IN A NORMAL FASHION. THE TRANSVERSE BOLTS OF THE CLAMP WERE TIGHTENED IN A FASHION TO ENSURE BOTH SIDES OF THE CLAMP WERE PARALLEL. UPON TIGHTENING ONE OF THE BOLTS (WHICH CAN NOW BE SEEN WITH THE DAMAGED THREAD INSERT( THE SURGEON SAID HE FELT THE BOLT GETTING A GOOD GRIP, THE CLAMP TIGHTENING ON THE PIN. HE CONTINUED TO TIGHTEN THE BOLT AND THEN FELT A SUDDEN RELEASE IN THE RESISTANCE ON THE BOLT. THIS RESULTED IN THE SPRING STYLE INSERT COMING LOSE FROM INSIDE THE CLAMP AND THEN BEING VISIBLE IN THE SPACE BETWEEN THE TWO SIDES OF THE CLAMP (AS CAN BE SEEN IN CURRENT STATE). THE CLAMP SIMULTANEOUSLY LOST ITS GRIP ON THE PIN. THE SURGEON THEN CHANGED THE CLAMP TO THE GREEN MRI COMPATIBLE VERSION (B)(4). THE SAME PROCESS OF APPLYING THIS REPLACEMENT CLAMP TO THE APEX PINS WAS REPEATED. THE SURGEON ENCOUNTERED THE SAME PROBLEM WITH ONE OF THE BOLTS LOSING ITS PURCHASE WITHIN THE CLAMP AND ALSO LOSING ITS GRIP ON THE PIN. THE GREEN MRI CLAMP IN ITS CURRENT STATE ALSO SHOWS A THREAD/SPRING STYLE INSERT IN THE OPENING SPACE BETWEEN THE TWO SIDES OF THE CLAMP. THE SURGEON THEN APPLIED ANOTHER REPLACEMENT CLAMP WHICH WAS SUCCESSFUL AND THE OPERATION CONTINUED. THE ORTHOPAEDIC TECHNICIAN WAS OBSERVING THE CASE AND REPORTS THAT EXCESSIVE FORCE DID NOT APPEAR TO BE USED WHEN THE SURGEON WAS TIGHTENING THE BOLTS ON THE CLAMPS. THE HOSPITAL IS CONCERNED WITH THE QUALITY OF (B)(4) PRODUCTS AND WOULD LIKE AN EXPLANATION OF WHAT MAY BE OCCURRING GIVEN THIS HAS HAPPENED ON NUMEROUS OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 HOLE PIN CLAMP HOFFMANN II IMPLANT JEC STRYKER OSTEOSYNTHESIS SELZACH NA J391466

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other