BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE F/SCREWDRIVER SHAFT 2.5 HEXAGONAL/STARDRIVE T15

    MDR report key: 8107797 · Received November 27, 2018

    Report

    Report Number
    8030965-2018-58507
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Report Date
    September 13, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819816831
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PART: 03.400.111; LOT: 8191678; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: JANUARY 29, 2013. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SELECTION: INVESTIGATION SITE: (B)(4); SELECTED FLOW: 5. BROKEN. VISUAL INSPECTION: A PIECE OF THE RECEIVED HANDLE FOR SCREWDRIVER SHAFT 2.5 WAS FOUND BROKEN AT THE PUSHING BUTTON. THE HOUSING SPRING WHICH WAS LOCATED UNDER THE BUTTON IS MISSING. DIMENSIONAL INSPECTION: THE CAUSE OF THE COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED BREAKAGE, THEREFORE NO DIMENSIONAL INSPECTION IS REQUIRED PER SELECTED INVESTIGATION FLOW BROKEN. DRAWING/SPECIFICATION REVIEW: THE CAUSE OF THE COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED BREAKAGE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS REQUIRED PER SELECTED INVESTIGATION FLOW BROKEN. MATERIAL REVIEW: THE CAUSE OF THE COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED BREAKAGE, THEREFORE NO MATERIAL REVIEW IS REQUIRED PER SELECTED INVESTIGATION FLOW BROKEN. SUMMARY: OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION IS CONFIRMED AS THE HANDLE IS NOT FUNCTIONING DUE THE VISIBLE DAMAGES. IT IS CLEARLY VISIBLE THAT THIS MALFUNCTION DIRECTLY RELATED TO THE BREAKAGE AT THE BLUE PLASTIC HANDLE AND THE MISSING SPRING. THIS DAMAGE WAS OBVIOUSLY CAUSED POST MANUFACTURING. BASED ON THE PROVIDED INFORMATION, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT THE HANDLE BROKE DURING A MECHANICAL OVERLOADING SITUATION DURING USE OR GOT DROPPED TO THE GROUND. THEREFORE, WE CAN CONFIRM THE VISIBLE DAMAGES ARE NOT FROM ANY MANUFACTURING NON-CONFORMITY. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS FOUND THAT A SCREWDRIVER HANDLE HAD NO SILVER BUTTON; THEREFORE, THE SCREWDRIVER SHAFT COULD NOT ASSEMBLE WITH THE HANDLE. IT WAS ALSO FOUND OUT THAT THERE WAS A CRACK IN THE HANDLE EXTENDING FROM WHERE THE BUTTON WAS SUPPOSED TO BE. IT WAS CONFIRMED THAT THE HANDLE HAD NOT BEEN TOUCHED SINCE IT WAS DISTRIBUTED TO THE HOSPITAL. THE EVENT DID NOT AFFECT THE SURGERY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES: SCREWDRIVER SHAFT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A HANDLE FOR SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945085 HANDLE F/SCREWDRIVER SHAFT 2.5 HEXAGONAL/STARDRIVE T15 SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH 8191678 07611819816831

    Patients

    Seq Age Sex Outcome Treatment
    1