BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER

    MDR report key: 3932776 · Received July 14, 2014

    Report

    Report Number
    1000562954-2014-10133
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME HWC. NONCONFORMANCE REPORTS (NCR (B)(4)) IS MENTIONED IN THE MANUFACTURING DOCUMENT, INDICATING THAT PART 04.111.531S / LOT 7960446 DROPPED DURING TRANSPORT. A CAUSAL RELATIONSHIP BETWEEN NCR (B)(4) AND THE CONDITION DESCRIBED IN (B)(4) IS ASSESSED AS VERY UNLIKELY. IT CAN BE CONCLUDED THAT THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A SMITH FRACTURE CASE (LEFT DISTAL RADIUS PART) THE SURGEON MOUNTED A GUIDING BLOCK TO THE PLATE AND ATTACHED THE DRILL SLEEVE, BUT IT DID NOT FIT IN PROPERLY. THEREFORE THE SURGEON INSERTED THE LOCKING SCREW BY HAND, THE SCREW DID NOT LOCK AND WENT THROUGH THE GUIDING BLOCK. SINCE OTHER SCREWS WERE INSERTED PROPERLY, THE SURGEON DID NOT REMOVE THE SCREW IN QUESTION. AFTER CHECKING THAT THE SCREW HAD NOT GONE THROUGH THE BACK SIDE, THE SURGEON COMPLETED THE OPERATION. THIS RESULTED IN A 10 MINUTE DELAY AND RESIDUE IN THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409152 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 7960446

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR