BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS

    MDR report key: 4111433 · Received September 23, 2014

    Report

    Report Number
    2530088-2014-10285
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT NO COMPLAINT IS FOR OILY RESIDUE FOUND. NO RESIDUE CAN BE FOUND ON THE RETURNED DEVICE. BECAUSE NO RESIDUE IS PRESENT THIS COMPLAINT IS UNCONFIRMED. DECONTAMINATION WAS PERFORMED PRIOR TO THIS MANUFACTURING EVALUATION AND THE DECONTAMINATION PROCESS MAY HAVE COMPROMISED THE FOREIGN SUBSTANCE. BECAUSE THE RESIDUE IS NOT PRESENT FURTHER TESTING WILL NOT BE PERFORMED. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS CONDUCTED. THE TIP OF THE SCREWDRIVER IS WORN, AND THE HANDLE HAS VARIOUS MARKS AND SCRATCHES. NO RESIDUE WAS NOTED ON THE RETURNED DEVICE. THE RETURNED DEVICES SHOW SIGNS OF ROUTINE USE DURING THEIR LIFESPANS. THE COMPLAINT CONDITION HAS TO DO WITH A RESIDUE ON THE HANDLES; BUT DUE TO DECONTAMINATION UPON RECEIPT OF THE COMPLAINT PARTS, THERE WAS NO RESIDUE PRESENT ON THE DEVICES. THUS THE COMPLAINT CONDITION IS UNCONFIRMED, AND WAS MOST LIKELY DUE TO REPEATED STERILIZATION CYCLES, WITH A LUBRICANT ADDITIVE PRESENT, OVER THE LIFE OF THE INSTRUMENTS. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. NO DESIGN DEFICIENCIES WERE DISCOVERED DURING THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE DEVICE HISTORY RECORD WAS REVIEWED AND MATERIAL REVIEW REPORT ( MRR) #(B)(4) WAS FOUND ON P/N 357.515.01 LOT #4895281 FOR SPOTS/UNEVEN FINISH ON 82 OUT OF 120 PARTS. THE NONCONFORMING PARTS WERE REWORKED, INSPECTED AND PASSED. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUE IS VISUAL ON THE BALL HEX SCREWDRIVER COMPONENT NOT FINISHED PRODUCT. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    SURGERY WAS DELAYED AND RE-SCHEDULED FOR (B)(6) 2014. RE-SCHEDULING OF SURGERY DID NOT CAUSE ANY ADVERSE EVENT TO PATIENT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE INSTRUMENTS IN A TROCHANTERIC FIXATION NAIL (TFN) SET WERE FOUND TO HAVE A CLEAR OILY RESIDUE DEPOSITED ON THE TRAYS UNDER THE SCREWDRIVER HANDLES. THIS WAS DISCOVERED PRIOR TO USE WHEN OPENING THE SETS FOR USE IN A PROCEDURE, NO PATIENT INVOLVEMENT AS THE SURGERY WAS RE-SCHEDULED. THIS IS REPORT 6 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589673 BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS GUIDE HXX SYNTHES BRANDYWINE 4936924

    Patients

    Seq Age Sex Outcome Treatment
    1