BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME LENGTHENER

    MDR report key: 4509230 · Received February 11, 2015

    Report

    Report Number
    3003875359-2015-10083
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Report Date
    January 30, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: FQP. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE SYNFRAME ACCESS AND RETRACTOR SYSTEM ALLOWS DIRECT VISUALIZATION AND STABLE RETRACTION FOR LESS INVASIVE SPINE SURGERY. THE CORE FUNCTION OF THE RING DEVICE SYSTEM IS TO PROVIDE A RIGID CONNECTION TO THE DESIRED RETRACTOR BLADES. TWO SYNFRAME LENGTHENERS WERE RETURNED WITH THE COMPLAINT THAT ¿DURING STERILE PROCESSING, IT WAS NOTICED THAT TWO SYNFRAME LENGTHENERS WERE MISSING A TOTAL OF FOUR SCREWS; TWO SCREWS FOR EACH SYNFRAME LENGTHENER. IN ADDITION, TWO SYNFRAME HALF RINGS WERE MISSING A TOTAL OF FOUR SCREWS: TWO SCREWS FOR EACH SYNFRAME HALF RING.¿ UPON RECEIPT OF THE SYNFRAME LENGTHENERS IT WAS SEEN THAT THE SCREWS ARE NO LONGER ATTACHED TO THE DEVICE, THIS COMPLAINT IS CONFIRMED. FOR THE TWO SYNFRAME HALF RINGS: WAS SERVICEABLE AND RETURNED TO CUSTOMER, THE OTHER ONE WAS NOT SERVICEABLE. A REPLACEMENT WAS ISSUED. A REVIEW OF THE MOST CURRENT DESIGN DRAWING WAS PERFORMED, THE DRAWING CALLS OUT AN ADHESIVE (LOCTITE) TO JOIN THE SCREW ASSEMBLY. THIS DESIGN RELIES ON THE ADHESIVE STRENGTH TO KEEP THE SCREW ASSEMBLY CONNECTED IN THE EVENT THE USER CONTINUES TO APPLY TORQUE ON THE SOCKET HEAD SCREW TO DISASSEMBLE THE CONSTRUCT. GIVEN THE AGE OF THESE DEVICES IT IS MOST LIKELY THAT FROM YEARS OF USE AND STERILIZATION CYCLES, THE ADHESIVE STRENGTH DIMINISHED, LEADING TO THIS CONDITION. THE DESIGN OF THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE AND THE RISK ASSESSMENT ADEQUATELY COVERS THE HAZARD ASSOCIATED WITH THIS COMPLAINT. 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

    (B)(4). SUBJECT DEVICE RECEIVED; NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE 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 DURING STERILE PROCESSING, IT WAS NOTICED THAT TWO SYNFRAME LENGTHENERS (387.338) WERE MISSING A TOTAL OF FOUR SCREWS; TWO SCREWS FOR EACH SYNFRAME LENGTHENER. IN ADDITION, TWO SYNFRAME HALF RINGS (387.337) WERE MISSING A TOTAL OF FOUR SCREWS: TWO SCREWS FOR EACH SYNFRAME HALF RING. NO SURGERY OR PATIENT INVOLVEMENT. THERE WERE NO REPORTED ISSUES WITH THE DEVICES PRIOR TO THIS DISCOVERY. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102179 SYNFRAME LENGTHENER MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 1169901

    Patients

    Seq Age Sex Outcome Treatment
    1