BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DSTRADIUS PL 6H HD/3H SHAFT/RT

    MDR report key: 3020686 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10624
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    April 17, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. PLACEHOLDER.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. NEW INFORMATION WAS RECEIVED (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF DISTAL RADIUS PROCEDURE SURGEON PLACED A TI 4.2MM VA-LCP 2-CLM 6 HOLE PLATE AND WAS INSERTING A 2.4MM TI VA LOCKING SCREW USING A 1.2NM TORQUE LIMITING ATTACHMENT, WHEN THE SCREW WENT THROUGH THE PLATE HOLE AT THE PROXIMAL HOLE ON THE MOST RADIAL SIDE OF THE PLATE DISTALLY. SURGEON DID NOT REMOVE THE SCREW; SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124037 2.4MM TI VA-LCP 2-CLMN VLR DSTRADIUS PL 6H HD/3H SHAFT/RT HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR