BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP DRSL DSTL RAD L-PLATE +90°/2H HD/3H SHAFT

    MDR report key: 3083415 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11199
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 25, 2012
    Report Date
    July 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PLATE IS BROKEN IN TWO PIECES AT THE FIRST SHAFT HOLE BELOW THE HEAD. THERE ARE SMALL MARKS ON EITHER SIDE OF THE HOLE WHERE THE PLATE WAS LIKELY HELD BY THE BENDING PLIERS TO CONTOUR THE PLATE. SINCE THIS PLATE BROKE PRIOR TO BEING IMPLANTED AND WAS DIRECTLY RELATED TO CONTOURING BY THE SURGEON THIS COMPLAINT IS DEEMED INVALID.

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURING EVALUATION SHOWED THE PLATE WAS BROKEN AT A VA LOCKING HOLE. THE RELEVANT DIMENSIONS AT THE BROKEN LOCKING HOLE CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. IT¿S CLEARLY VISIBLE THAT THE PLATE WAS BENT IN DIFFERENT DIRECTIONS BEFORE IS BROKE. THEREFORE WE SUPPOSE THAT EXCESSIVE CONTOURING CAUSED THIS BREAKAGE. THE PRODUCT DEVELOPMENT EVALUATION SHOWED THAT THE 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATE IS DESIGNED OF COMMERCIAL PURE TITANIUM, GRADE 4, WHICH IS A STANDARD MATERIAL FOR METALLIC TRAUMA IMPLANTS. THE HOLE DIMENSIONS ARE BY (B)(4), THE CORRECT STANDARD FOR THE DESIGN OF 2.4MM VA LOCKING HOLES. THE PLATE IS ALSO OF AN APPROPRIATE THICKNESS FOR ITS ASSOCIATED INDICATIONS. THE FINISHING AND ETCHING IS STANDARD FOR AN IMPLANT OF THIS SIZE, AS IS THE PACKAGING AND STERILITY. A TECHNIQUE GUIDE EXISTS TO EXPLAIN THE PROPER USE AND HANDLING OF THE IMPLANT AND ASSOCIATED SYSTEM. SINCE THIS PLATE BROKE PRIOR TO BEING IMPLANTED AND WAS DIRECTLY RELATED TO CONTOURING BY THE SURGEON THIS COMPLAINT IS DEEMED INVALID. PRODUCT DEVELOPMENT EVALUATION RECEIVED ON 8/29/12. MANUFACTURING EVALUATION RECEIVED ON 10/10/12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS CONTOURING PLATE, PRIOR TO IMPLANT, THE PLATE BROKE. SURGEON USED ANOTHER PLATE AND WAS ABLE TO COMPLETE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184802 2.4MM TI VA-LCP DRSL DSTL RAD L-PLATE +90°/2H HD/3H SHAFT HRS SYNTHES GMBH 3651544

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR