BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCER

    MDR report key: 3083381 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10988
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ROD INTRODUCER WAS MANUFACTURED BY INSTRUMED. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND FUNCTIONAL TESTING WAS PERFORMED TO EVALUATE THE VALIDITY OF THE COMPLAINT. IT WAS EVIDENT THAT THE CROSS SHAFT WAS NOT FULLY RETRACTING AS STATED. AFTER DISASSEMBLY OF THE ROD INTRODUCER, THE SPRING THAT RETRACTS THE CROSS SHAFT SHOWED DEFORMATION, WHICH WOULD LIMIT THE LENGTH OF TRAVEL DURING THE RETRACTION PHASE OF OPERATION. ALSO NOTED DURING THE DISASSEMBLY WAS AN OILY RESIDUE ON THE CROSS SHAFT AND SHAFT ASSEMBLY. AUTOCLAVE HAD BEEN PERFORMED, BUT SOME TYPE OF FLUID TRANSFERENCE IS EVIDENT. THE BIOMEDFLEX COATING IS APPLIED TO THESE TWO COMPONENTS TO ELIMINATE THE USE OF LUBRICANTS. SINCE INSTRUMED DID NOT USE ANY CUTTING FLUIDS DURING DISASSEMBLY, THIS RESIDUE WAS INSIDE THE INSTRUMENT WHEN IT WAS RECEIVED. INSTRUMED CONCLUDED THAT THE PRODUCT WAS MADE TO PRINT AND WAS FUNCTIONAL UP THROUGH ACCEPTANCE AT SYNTHES. HOWEVER, WHEN THE ROD INTRODUCER WAS RETURNED TO INSTRUMED, IT WAS NOT FUNCTIONING AS IT HAD PRIOR TO SHIPMENT. THE PARTS CONFORMED TO SPECIFICATIONS AT THE TIME OF MANUFACTURING. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY INSTRUMED, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THE ORIGINAL DATE OF AWARENESS FOR THIS REPORT IS HEREBY CORRECTED TO (B)(6) 2011. THE EARLIEST MANUFACTURER AWARENESS DATE FOR THE CORRECTIONS CONTAINED HEREIN IS (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPRING AT THE TIP WAS BROKEN. THE INSTRUMENT WAS USED IN A WORKSHOP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184967 ROD INTRODUCER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 6486527

    Patients

    Seq Age Sex Outcome Treatment
    1