BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 3013103 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-00886
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT RECEIVED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION. CONNECTING SCREW HANDLE-NAIL NOT TIGHTENING AFTER NAIL INSERTION MAY LEAD TO A MISALIGNMENT OF THE INSTRUMENTS. A DISTANCE BETWEEN THE DRILL SLEEVE TIP AND THE CORTEX SCREW MAY LEAD TO SLIPPING OF THE GUIDE WIRE OR DRILL BIT ON THE CORTEX SCREW AND THEREFORE MAY LEAD TO A MISMATCH OF THE INSTRUMENTS. THE DEVICE WAS SENT TO THE PLANT FOR EVALUATION AND HAS BEEN TESTED AND IS FULLY FUNCTIONAL. THE DEVICE HAS BEEN MEASURED AND FOUND TO BE ACCORDING TO THE GIVEN SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS IS 2 OF 5 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 THE SURGEON WAS ATTEMPTING TO USE THE PROXIMAL LOCKING WITHOUT THE AFN NAIL CONSTRUCT AND COULD NOT GET THE 2.8MM GUIDEWIRE TO GO THROUGH THE DISTAL RECON HOLE OF THE NAIL. REPORTEDLY THE SURGEON REMOVED THE PROXIMAL PART OF THE NAIL FROM THE PATIENT AND RECHECKED THE ALIGNMENT OF THE JIG TO THE NAIL THIS SEEMED TO BE FINE WHEN OUT OF THE PATIENT. THE NAIL WAS THEN REINSERTED AND SLIGHT FORCE ON THE NAIL CAUSED THE ALIGNMENT TO BE OFF AND THE SLEEVES WERE AIMED TO THE WIRE ANTERIOR TO THE NAIL. THE SURGEON THEN INSERTED THE REAMER INTO THE HEAD WHICH REAMED THROUGH THE ANTERIOR OF THE NAIL. THIS IS FOR THE CONNECSCR F/CFN/AFN F/SYNREAM. THIS IS 2 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116444 CONNECSCR F/CFN/AFN F/SYNREAM FZX SYNTHES GMBH 2633255

    Patients

    Seq Age Sex Outcome Treatment
    1