BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE 1.5MM DRILL BIT MQC W/12MM STOP/50MM

    MDR report key: 6540741 · Received May 3, 2017

    Report

    Report Number
    1719045-2017-10399
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Report Date
    April 7, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZI
    UDI-DI
    07611819383043
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT. DATE OF DEVICE BREAKAGE IS NOT KNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW FOR PART #03.503.512, SYNTHES LOT# U114794. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 12-JAN-2010, 26-JAN-2010, 09-FEB-2010, 04-MAR-2010, 18-MAR-2010, 02-APR-2014 SUPPLIER: (B)(6). 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

    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

    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

    THE VISUAL INSPECTION OF THE RETURNED DRILL BIT HAS SHOWN THAT APPROXIMATELY 9 MM FROM THE FLUTED TIP SECTION IS BROKEN OFF. THE BROKEN TIP WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY THERE ARE A LOT OF WEAR MARKS AND SCRATCHES AT THE WHOLE INSTRUMENT VISIBLE. THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THESE PARTS WERE MANUFACTURED AT A SUPPLIER. THE INCOMING INSPECTION AFTER THE MANUFACTURING OF THE PRODUCTS HAS SHOWN NO DEVIATIONS OR NON-CONFORMANCES. THE PARTS WERE MEASURED AND THE REVIEW OF THE DHR REVIEW HAS SHOWN THAT THE CORRECT MATERIAL WAS USED. MEASUREMENT OUTER DIAMETER Ø1.5: RESULT: Ø1.5 "PASS" DHR REVIEW, NO FINDINGS CHU EVALUATION, NO FINDINGS. BASED ON THESE FINDINGS WE EXCLUDE ANY MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS BREAKAGE. WE ONLY CAN ASSUME THAT A MECHANICAL OVERLOADING SITUATION, FOR EXAMPLE METALLIC CONTACT OR LATERAL STRESS, HAS CAUSED THE BREAKAGE. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THE DRILL BIT WITH STOP WAS RECEIVED BROKEN. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT WITH STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323043 MATRIXMANDIBLE 1.5MM DRILL BIT MQC W/12MM STOP/50MM DRILL, BONE, POWERED DZI SYNTHES MONUMENT U114794 07611819383043

    Patients

    Seq Age Sex Outcome Treatment
    1