BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW GAMMA3 8X35MM

    MDR report key: 3056427 · Received April 12, 2013

    Report

    Report Number
    0009610622-2013-00194
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION REVEALED THE NHS TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR MORE THAN ONE YEAR WE PRESUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE DAMAGES OF THE NHS HEAD AND ON THE TIP OF THE STRIKE PLATE INDICATE THAT THE STRIKE PLATE WAS NOT INSERTED CORRECTLY INTO THE NHS TO INSERT THE NAIL. HAMMER SIGNS ON THE STRIKE PLATE HEAD INDICATE THAT THE NAIL WAS INSERTED WITH HIGH FORCES. DUE TO THIS HIGH FORCES IN COMBINATION WITH THE INCORRECT ASSEMBLING OF STRIKE PLATE AND NHS THE NHS HEAD GOT HEAVILY DEFORMED AND A DISASSEMBLING OF THE NHS (AND THEREFORE OF TARGET DEVICE AND NAIL TOO) WAS NO LONGER POSSIBLE. THE FACT THAT THE NAIL WAS HEAVILY DRILL MARKED AND THE NAIL WAS NOT TIGHTENED COMPLETELY TO THE TARGET DEVICE INDICATES THAT THE NHS WAS NOT TIGHTENED PRIOR TO NAIL INSERTION; A PRE DAMAGING OF THE NHS COULD NOT BE EXCLUDED. THE IFU AND OPERATIVE TECHNIQUE INCLUDES THAT THE USER SHALL BE CONVERSANT WITH THE HANDLING OF THE SYSTEM AND THAT ALL INSTRUMENTS SHALL BE CHECKED PRIOR EVERY SURGERY. THEREFORE THE ISSUE WAS CLASSIFIED AS USER RELATED. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GAMMA NAIL WAS USED TO TREAT PATIENTS HIP FX. AT THE CONCLUSION OF THE CASE AFTER TAKING FINAL X-RAYS, THE TARGETER WOULD NOT DISENGAGE FROM THE GAMMA NAIL. AS A RESULT, WE HAD TO REMOVE THE NAIL FROM THE PATIENT AND INSERT A NEW GAMMA NAIL INSTEAD. (10X340/125 RIGHT) THE OUTCOME WAS SATISFACTORY AND DIDN'T COMPROMISE THE PATIENT IN THE O.R.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GAMMA NAIL WAS USED TO TREAT PATIENTS HIP FX. AT THE CONCLUSION OF THE CASE AFTER TAKING FINAL X-RAYS, THE TARGETER WOULD NOT DISENGAGE FROM THE GAMMA NAIL. AS A RESULT, WE HAD TO REMOVE THE NAIL FROM THE PATIENT AND INSERT A NEW GAMMA NAIL INSTEAD. (10X340/125 RIGHT) THE OUTCOME WAS SATISFACTORY AND DIDN'T COMPROMISE THE PATIENT IN THE O.R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158813 NAIL HOLDING SCREW GAMMA3 8X35MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K844634

    Patients

    Seq Age Sex Outcome Treatment
    1 Other