BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VG2 CERVICAL CPK TIP

    MDR report key: 4326946 · Received December 12, 2014

    Report

    Report Number
    1526439-2014-12213
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    November 18, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INITIAL MFG. MEDWATCH REPORT HAD BEEN FILED AS A RESULT OF EXPRESSCARE KIT INSPECTION NOTING ONE LOOSE AND ONE PIN MISSING FROM THE VG2 CERVICAL CPK TIP. HOWEVER, AFTER RE-EVALUATION OF THE USE AND HANDLING OF THE INSTRUMENT AND OF SIMILAR COMPLAINTS THAT HAVE BEEN REPORTED, IT HAS BEEN DETERMINED THAT PIN SEPARATION WOULD BE HIGHLY DETECTIBLE IF IT WERE TO OCCUR IN SURGERY AND THAT THE CONDITION LIKELY OCCURRED PRIOR TO AND NOT DURING A SURGICAL PROCEDURE. THE PIN SEPARATION LIKELY OCCURRED DURING ROUTINE HANDLING, STERILE PROCESSING, AND/OR SHIPPING. AS SUCH, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION AND NO FOLLOW UP REPORTS WILL BE SUBMITTED REGARDING THIS ISSUE. 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

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    INSPECTION OF A RETURNED EXPRESSCARE KIT BY DEPUY SYNTHES SPINE FOUND ONE PIN FROM THE VG2 CERVICAL CPK TIP TO BE MISSING FROM THE INSTRUMENT AND A SECOND PIN WAS LOOSE. IT IS NOT KNOWN WHEN/THE MISSING TIP BECAME SEPARATED FROM INSTRUMENT OR WHERE IS IT LOCATED. THERE HAD BEEN NO REPORT OF ANY ADVERSE CONSEQUENCES TO A PATIENT OR DELAY. HOWEVER, AS IT IS POSSIBLE THAT THE BROKEN PIN REMAINS IN A PATIENT, THIS MEDWATCH REPORT IS BEING FILED TO DOCUMENT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809090 VG2 CERVICAL CPK TIP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE R0812

    Patients

    Seq Age Sex Outcome Treatment
    1