BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM SETSCREW EXTRACTOR

    MDR report key: 3782191 · Received April 30, 2014

    Report

    Report Number
    1719045-2014-10166
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL DEVICE MANUFACTURE DATE 01/31/2012. TELEFLEX MEDICAL, INC (PRESENTLY TECOMET ) MANUFACTURED THE 3.5MM SET SCREW EXTRACTOR, ¼¿ SQUARE DRIVE, P/N 03.611.034, LOT # 6818415. THE CERTIFICATES OF COMPLIANCE INDICATE THE LOT WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS, PER THE SYNTHES DRAWING. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES TABULATED INCOMING FINAL INSPECTION SHEET. THERE WERE NO COMPLAINT-RELATED ISSUES, MANUFACTURING REPORT ISSUES, OR NONCONFORMANCE REPORTS ASSOCIATED WITH THIS LOT. THE SET SCREW EXTRACTOR WAS MANUFACTURED TO THE SYNTHES DRAWING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ORIGINAL REPORT INDICATED THE INCORRECT DATE OF MANUFACTURE THE ERROR WAS A TYPO THAT INDICATED JANUARY 1, 2012IF 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 EVALUATION WAS COMPLETED: SCREW EXTRACTOR (PART 03.611.034 LOT 6818415) WAS RETURNED WITH THE THREADED TIP BROKEN. THE BROKEN PIECE WAS SEEN IN THE RECESS OF THE RETURNED SCREW. THERE WERE SCRATCHES ALONG THE SQUARE DRIVE CONSISTENT WITH NORMAL USE. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE LOCKING SCREW IS DESIGNED WITH A 3.5MM HEX PER (B)(4) AND THE EXTRACTOR IS DESIGNED WITH A 3.8MM THREADED TIP. THE EXTRACTOR THREADS INTO A DAMAGED SCREW HEAD CAUSING THE RECESS TO DEFORM AND CREATING RETENTION FOR REMOVAL. THIS EXTRACTOR IS INCLUDED IN A SPINE REMOVAL SET AND THEREFORE INTENDED FOR SPINE SCREWS WHILE THE SCREW IT BROKE OFF IN IS PART OF A TRAUMA SYSTEM. IN ADDITION, THE TROCHANTERIC FIXATION NAIL TECHNIQUE GUIDE INSTRUCTS THE USER TO USE A 3.5MM HEXAGONAL SCREWDRIVER FOR REMOVING THE LOCKING SCREW. EVIDENCE STRONGLY SUGGESTS THE EXTRACTOR WAS MISUSED TO REMOVE A TROCHANTERIC FIXATION NAIL LOCKING SCREW AND IT WAS NOT THE DESIGN THAT CONTRIBUTED TO THE COMPLAINT. THE TECHNIQUE GUIDE FOR THE TFN SCREW LISTS HEXAGONAL SCREWDRIVER 314.75 TO BE USED FOR REMOVAL AND THE EXTRACTOR IS INTENDED TO BE USED FOR SPINE SCREWS. THESE TWO DEVICES ARE NOT INTENDED TO BE USED TOGETHER AND THEREFORE THE DESIGN DID NOT CONTRIBUTE TO THE EXTRACTOR BREAKING. 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

    IT WAS REPORTED THAT A 3.5MM SETSCREW EXTRACTOR (03.611.034) HAS A SCREW STUCK ON THE END OF IT. THE ISSUE WAS DISCOVERED AFTER THE SALES CONSULTANT RECEIVED THE EQUIPMENT FROM CLEANING. THERE WERE NO REPORTED ISSUES WITH THE DEVICES PRIOR TO DISCOVERY. THE SALES CONSULTANT ATTEMPTED TO BACK THE SCREW OUT OF THE EXTRACTOR TO REUSE IT BUT THREADED THE SCREW AND BROKE THE TIP OF THE EXTRACTOR IN THE PROCESS. THERE IS NO PATIENT OR CASE INVOLVEMENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259731 3.5MM SETSCREW EXTRACTOR MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 6818415

    Patients

    Seq Age Sex Outcome Treatment
    1