BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM

    MDR report key: 6689241 · Received July 6, 2017

    Report

    Report Number
    3000270450-2017-10229
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    June 9, 2017
    Report Date
    June 9, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER IS NOT AVAILABLE FOR REPORTING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 03.130.202S, LOT # L113564: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4). MANUFACTURING DATE: 14.SEP.2016, EXPIRY DATE: 01.AUG.2026: NO NON CONFORMANCE REPORTS (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. NON-STERILE 03.130.202 / F-20217: MANUFACTURING LOCATION: SUPPLIER SPHINX AG, MANUFACTURING DATE:20.JUL.2016: 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    CONCOMITANT DEVICE: DRILL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED DRILL BITS WERE USED IN SURGERY FOR ARTHRODESIS FOR CARPOMETACARPAL OSTEOARTHRITIS OF THUMB ON (B)(6) 2017.WHEN A NURSE WAS HANDLING THE FIRST DRILL BIT ON THE SURGICAL TABLE THE DRILL BIT ACCIDENTALLY HIT A PETRI DISH AND BROKE. THE SURGEON REPLACED IT WITH A SECOND DRILL BIT AND STARTED DRILLING. THEN THE SECOND DRILL BIT BROKE IN THE PATIENT'S BODY. THE BROKEN FRAGMENT WAS REMOVED. IT IS UNKNOWN WHICH OF THE DRILL BITS WAS USED AT FIRST AND WHICH ONE AS SECOND. THE SURGEON COMMENTED THAT HE MIGHT HAVE PUT AN EXTRA LOAD TO THE SECOND DRILL BIT AGAINST THE PATIENT'S SOLID BONE QUALITY. THE SURGERY WAS COMPLETED WITH A TEN (10) MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PATIENT OUTCOME IS REPORTED AS OKAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472085 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM BIT, DRILL HTW SYNTHES SELZACH L113564

    Patients

    Seq Age Sex Outcome Treatment
    1