BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T4/66MM

    MDR report key: 3230084 · Received July 16, 2013

    Report

    Report Number
    2530088-2013-01055
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS REPORT STATES THAT THE MANUFACTURING DOCUMENTS COULD NOT VERIFY THE PART AND LOT NUMBER. THE REPORT STATES THAT THE LOT # 6562738 CORRESPONDS TO PART #405.508.2 AND NOT THE COMPLAINT PART.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: REPORTABLE TO NON-REPORTABLE. DOES NOT MEET THE DEFINITION OF AN MDR REPORTABLE EVENT. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE PRODUCT LED TO A SERIOUS INJURY OR DEATH. ¿THE SALES CONSULTANT REPORTED THAT DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) FIFTH METACARPAL PROCEDURE THE, WHILE INSERTION OF THE COMBINATION SCREWS AND LOCKING SCREWS THE HEAD OF THE T4 SCREWDRIVER BROKE. NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SWITCHING TO A NEW INSTRUMENT. PER SALES CONSULTANT THERE WAS NO FRAGMENTATION OF THE SCREWDRIVER TIP.¿ THERE WAS NO REPORT OF FRAGMENTATION. THIS WAS A RECOGNIZABLE EVENT AND THE PRODUCT COULD BE EASILY REPLACED. THERE IS NO REPORT OF AN EXTENDED REPORTABLE SURGICAL DELAY. A PRODUCT SHOULD BE INSPECTED BEFORE USE. IF A PRODUCT APPEARS TO BE SUBSTANDARD IT SHOULD BE REPLACED, NOT USED. IT IS THE RESPONSIBILITY OF THE MEDICAL STAFF OR EQUIPMENT USER TO SELECT THE PROPER PRODUCT AND USE THE PROPER TECHNIQUES AND PROCEDURES FOR SUCCESSFUL OUTCOME. THERE WAS NO REPORT OF INJURY TO ANY PATIENT. THIS COMPLAINT IS NOT A REPORTABLE EVENT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF), FIFTH METACARPAL PROCEDURE, WHILE INSERTING THE COMBINATION SCREWS AND LOCKING SCREWS, THE HEAD OF THE T4 SCREWDRIVER BROKE. NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SWITCHING TO A NEW INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329715 STARDRIVE SCREWDRIVER SHAFT T4/66MM HXX SYNTHES BRANDYWINE 6562738

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR