BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYN-LOCK-SCR Ø3.7 SELF-TAP L26 COCRMO

    MDR report key: 3183618 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03744
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    December 31, 2011
    Report Date
    January 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K110592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION CARRIED OUT, IN ADDITION TO THE MANUFACTURING AND ITEM DOCUMENTATION, HAS SHOWN THAT THIS DLS, DISTAL LOCKING SCREW, WAS MANUFACTURED IN OCTOBER 2011 ACCORDING TO SPECIFICATION. IT CAN ALSO BE RECOGNIZED, BY MEANS OF A MICROSCOPE, THAT THE PIN IS NOT CENTRAL. THE FINDINGS CONCLUDE THAT THE DAMAGE WAS CAUSED BY THE REMOVAL OF THE SCREW. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. NONETHELESS, ALL EXPERIENCE IS CURRENTLY BEING GATHERED FROM THE TEST MARKETS, AS THIS IMPLANT IS IN THE MARKET PREFERENCE EVALUATION PHASE. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO PRODUCT FAULT COULD BE DETECTED. AS THE FINDINGS CONCLUDE THAT THE DAMAGE WAS CAUSED BY THE REMOVAL OF THE SCREW, THIS DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. EXPIRATION DATE: 10/01/2020. MFR DATE : 10/19/2010. DATE OF EVENT: (B)(6) 2011. THIS IS SOLD IN THE US NOT JUST THE EU, K110592.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE DISTAL LOCKING SCREW NEEDED TO BE EXCHANGED FOR UNCLEAR REASONS. IT WAS VERY DIFFICULT TO REMOVE THIS SCREW, BUT FINALLY IT COULD COMPLETELY BE REMOVED WITHOUT ANY SCREW OR PIN BREAKAGE, HOWEVER, IT WAS NOTED THAT THE PIN IS NO LONGER IN THE CENTER. IT IS UNCLEAR IF THE PIN WAS RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284343 DYN-LOCK-SCR Ø3.7 SELF-TAP L26 COCRMO HWC SYNTHES GMBH 2643275

    Patients

    Seq Age Sex Outcome Treatment
    1