BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA

    MDR report key: 6505488 · Received April 19, 2017

    Report

    Report Number
    1719045-2017-10331
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Date of Event
    March 27, 2017
    Report Date
    March 27, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HAW
    UDI-DI
    10705034719764
    PMA / PMN Number
    K122211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 03.632.316, LOT # 6975892: RELEASE TO WAREHOUSE DATE: 03-JUL-2013, 17-JUL-2013, 03-DEC-2013, 07-MAR-2014, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE FOLLOWING COMPLAINT DEVICE(S) WAS RECEIVED BY CUSTOMER QUALITY (CQ): ONE NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA (PART NUMBER: 03.632.316, LOT NUMBER: K122211, MFG DATE: 03JUL2013). A VISUAL INSPECTION AND DEVICE HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION COULD BE CONFIRMED AS THE TROCAR LOCK HAS BROKEN OFF FROM THE BUTTON PIN. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS IT¿S ALREADY BROKEN. BALANCE OF THE DEVICE IS IN FAIR CONDITION. THIS COMPLAINT IS CONFIRMED. THE RETURNED INSTRUMENT IS PART OF THE SYNTHES NAVIGATED INSTRUMENTS FOR MATRIX AND MATRIX MIS SPINE SYSTEMS. THE INSTRUMENT IS UTILIZED IN THE WITH THE INNER SHAFT (03.632.313) AND PEDICLE ACCESS CANNULA SHAFT (03.632.322) TO PERFORATE THE CORTEX OF THE PEDICLE PRIOR CANNULATED SCREW INSERTION PER RELEVANT TECHNIQUE GUIDE. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED; HOWEVER, THE COMPLAINT MAY BE DUE IMPACTION ON THE DEVICE DURING THE PROCEDURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    ADDITIONAL PRODUCT CODE: OLO. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AND POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2017 FROM L4 TO S1, A SMALL PIECE OF THE QUICK COUPLING ATTACHMENT SHEARED OFF DURING IMPACTION. THERE WAS A 10 MINUTE DELAY; THE SURGERY WAS COMPLETED WITH NO REPORTED HARM TO THE PATIENT. THERE WERE NO REPORTED FRAGMENTS IN THE PATIENT. THIS REPORT IS FOR ONE (1) NAVIGABLE HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285158 NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA NEUROLOGICAL STEREOTAXIC INSTR HAW SYNTHES MONUMENT 6975892 10705034719764

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR