BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 HOLE PIN CLAMP HOFFMANN II MRI 4-6MM

    MDR report key: 2140590 · Received June 16, 2011

    Report

    Report Number
    8031020-2011-00139
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXT
    PMA / PMN Number
    K051306
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL CAT # 4921-2-020, LOT # H11794.

    Description of Event or Problem · 1

    THE HOSPITAL IS NOT SATISFIED WITH THE PRODUCT PERFORMANCE AND LONGEVITY OF THE MULTIHOLE PIN CLAMP (49212020). THEY REPORT THAT THE BOLTS OFTEN DO NOT EASILY TIGHTEN INTO THE BLOCKS. THEY ALSO SAY THAT THE COMPONENTS APPEAR TO BUILD UP SOME SORT OF RESIDUE ON THE THREADS OF THE BOLTS AND BLOCKS. THERE ARE VARYING DEGREES OF RESISTANCE ON EACH BOLT AND THIS VARIES BETWEEN DIFFERENT PIN CLAMPS. THE HOSPITAL REPORTS THAT EVEN WHAT APPEAR TO BE BRAND NEW PIN CLAMPS WITH MINIMAL USAGE ARE STILL SUSCEPTIBLE TO THE ISSUE. ONE OF THE MULTIHOLE CLAMPS (49212020 LOT N16509) APPEARS TO HAVE A CROSS THREADED BOLT. THE HOSPITAL SAY THAT THIS SEEMS TO HAPPEN MORE FREQUENTLY WITH THE NEW MRI COMPATIBLE CLAMPS (49212020) COMPARED TO THE PREVIOUS NON MRI EQUIVALENT (49202020). THE HOFFMANN COMPACT MULTI HOLE PIN CLAMP (49402020 LOT H11794) IS REPORTED TO HAVE A JAMMED BOLT THAT CAN'T BE REMOVED. VISUALLY, IT APPEARS TO BE DAMAGED ALSO. THE HOSPITAL BELIEVES THAT THE CHANGE IN DESIGN BETWEEN THE MRI AND NON MRI MODELS OF OUR PIN CLAMPS, INCLUDING THE CHANGE IN THE REMOVAL OF THE SPRING THREAD INSERT IN THE BLOCKS COULD BE A CONTRIBUTING FACTOR IN THE PROBLEMS THEY EXPERIENCE WITH OUR PRODUCT. THEY REPORT THAT THE NON MRI COMPONENTS HAVE MUCH BETTER PERFORMANCE IN TERMS OF RELIABILITY AND LONGEVITY. THE HOSPITAL IS A MAJOR LEVEL 1 TRAUMA CENTRE WHO DO A LOT OF EXTERNAL FIXATION WORK. THIS ISSUE WITH THE BOLTS AND CLAMPS HAVE BEEN REPORTED PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 HOLE PIN CLAMP HOFFMANN II MRI 4-6MM IMPLANT LXT STRYKER OSTEOSYNTHESIS SELZACH NA W21924 W31516

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other