BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 3882408 · Received June 18, 2014

    Report

    Report Number
    9612488-2014-10233
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS RECEIVED CONDITION OF DEVICE; ALL DEVICES ARE CLEAN, INSERTION HANDLE WITHOUT DAMAGES, NAIL SLIGHTLY DISCOLORED, WORN CONNECTING SCREW. THE RETURNED COMPONENTS WERE VISUALLY INSPECTED AND COMPARED TO STANDARD COMPONENTS. A SIMPLE HANDLING TEST WAS PERFORMED. THE RETURNED SCREW COULD NOT BE INSERTED INTO THE INSERTION HANDLE DEEPER AS THE SCRATCHES IN THE MIDDLE OF THE SHAFT. THE CLEARANCE BETWEEN THE SCREW SHAFT AND THE SCREW HOLE OF THE HANDLE WAS VERY SMALL. THE RETURNED CONNECTING SCREW COULD BE MOUNTED ON THE NAIL WITHOUT THE INSERTION HANDLE. THE CLEARANCE BETWEEN THE SCREW SHAFT AND THE SCREW HOLE OF THE HANDLE WAS LARGER THAN THE RETURNED PRODUCTS. BOTH RETURNED AND STANDARD NAIL COULD BE MOUNTED ON BOTH THE RETURNED AND STANDARD INSERTION HANDLE USING THE STANDARD SCREW WITHOUT ANY ADVERSE EFFECT. BOTH RETURNED AND STANDARD NAIL COULD NOT BE MOUNTED ON BOTH THE RETURNED AND THE STANDARD INSERTION HANDLE USING THE RETURNED SCREW. THE TIP DEFORMATION OCCURRED PROBABLY BY STRIKING ON THE SCREW TIP TO REMOVE IT FROM THE INSERTION HANDLE. THIS MISSING COLOURS IN THE RING AREA AND THE MARGINAL DISCOLORATION OF THE NAIL ARE NEITHER RESPONSIBLE FOR THE JAMMING OF THE SCREW. THE SCRATCHES ON THE SHAFT RESULTED IN A SLIGHT INCREASE OF THE DIAMETER OF THE SCREW (8.21MM) THAT LEADS TO THE JAMMING IN THE INSERTION HANDLE (MINIMUM DIAMETER 8.2MM). THIS IS CONFIRMED BY THE SIMPLE HANDLING TEST PERFORMED. THE SCRATCHES ON THE SCREW MAY ARE CONSISTENT WITH THE INTRA OPERATIVE RE-TIGHTENING OF THE NAIL WHICH OCCURRED WHILE AND BECAUSE THE SYSTEM WAS LOADED. THE SCRATCHES ARE ALSO CONSISTENT WITH THE AGE OF THE SCREW. SYNTHES IMPORTANT INFORMATION CLEARLY STATES THAT INSTRUMENTS SHOULD BE INSPECTED FOR E.G. EXCESSIVE SCRATCHES, WEAR OR PROPER FUNCTION. 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: ANTEGRADE FEMORAL NAIL (AFN) WAS ATTACHED TO INSERTION HANDLE WITH CONNECTION SCREW BY SCRUB NURSE, AND APPEARED TO BE SECURELY FASTENED. THE ALIGNMENT WAS CHECKED WITH SLEEVES AND K WIRES PRIOR TO HANDING TO THE SURGEON. THE SURGEON¿S FELLOW SIGHTED SLEEVE AND K-WIRE LINING UP WITH RECON APERTURES OF NAIL AND CONFIRMED CONNECTION SCREW WAS SECURE. NAIL INSERTED INTO PATIENT AND CONNECTION BECAME NOTABLY LOOSE. THE SURGEON USED THE BALL TIPPED SCREW DRIVER TO TIGHTEN THE CONNECTION SCREW (WHILE THE NAIL SEMI INSERTED INTO PATIENT) BUT THE NAIL CONNECTION TO INSERTION HANDLE REMAINED LOOSE. THE NAIL WAS REMOVED FROM PATIENT AND APPEARED TO BE TIGHTLY CROSS THREADED. THE SURGEON WAS ABLE TO REMOVE THE NAIL FROM THE CONNECTION BOLT / INSERTION HANDLE; HOWEVER, THE CONNECTION SCREW HAD JAMMED INTO THE INSERTION HANDLE AND COULD NOT BE REMOVED. ANOTHER STERILE SET WAS USED TO COMPLETE THE PROCEDURE; THIS CAUSED APPROXIMATELY 20-25 MINUTE DELAY IN OPERATING TIME. THE OUTCOME RELATING TO IMPLANT FIXATION WAS NOT AFFECTED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356873 CONNECSCR F/CFN/AFN F/SYNREAM GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES BETTLACH 2024751

    Patients

    Seq Age Sex Outcome Treatment
    1