BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM

    MDR report key: 6570321 · Received May 16, 2017

    Report

    Report Number
    2520274-2017-11646
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 18, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    UDI-DI
    07611819775374
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER U243601. MANUFACTURING LOCATION: SYNTHES (B)(4)--SUPPLIER ((B)(4)). DATE OF MANUFACTURE: 05/07/2016. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM, PART NUMBER 03.010.100, LOT NUMBER U243601). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING: THE DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP ARTICLE NO. 03.010.100 BATCH NO. U243601 WAS VISUALLY INSPECTED BY COMPLAINT TECHNICAL INVESTIGATOR (B)(6). INSPECTION RESULTS: THE REPORTED FAILURE COULD NOT BE CONFIRMED. NO FAILURE COULD BE FOUND ON THE DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP. ROOT CAUSE: NO ROOT CAUSE CAN BE ASSIGNED AS NO FAILURE WAS FOUND ON THE DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP. 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 NARRATIVE: MANUFACTURING EVALUATION WAS COMPLETED TO CHECK THE DIMENSIONS OF THE DRILL BIT (03.010.100; LOT NO. U243601). FIRST VISUAL CHECK DID NOT REVEAL ANY DEVIATIONS. THE DIMENSIONS OF THE DRILL BIT WERE CHECKED. IT WAS IDENTIFIED THAT THE TIP OF THE REPORTED DRILL BIT WAS SLIGHTLY DAMAGED. THE MOST PROBABLE ROOT CAUSE OF THE FAILURE IS WRONG HANDLING. INSPECTION RESULTS (THE DIMENSIONS WERE CHECKED) SHOW THAT THE PRODUCT WAS DAMAGED BY DROPPING. THE CUTTER CANNOT BE USED ANYMORE, IT NEEDS TO BE REPLACED. THIS COMPLAINT IS CONFIRMED. 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 WAS REPORTED THE DEVICES WERE USED IN SURGERY TO REMOVE A MALIGNANT BONE TUMOR OF HUMERUS ON (B)(6) 2017. THE REPORTED RADIOLUCENT DRIVE WAS USED IN DISTAL SIDE STOPPAGE WHEN THE SURGEON APPLIED MULTILOC HUMERAL NAIL (MHN) SYSTEM. DURING THE DRILLING, THE RADIOLUCENT DRIVE MADE NOISE AND STOPPED. THE SURGEON PULLED IT OUT FROM THE BODY AND CHECKED IF IT COULD RUN PROPERLY; HE CONFIRMED THAT IT RAN NORMALLY. BUT THE RE-DRILLING RESULTED IN ANOTHER NOISE, AND IT STOPPED AGAIN. AS THE SURGEON ATTRIBUTED THE MALFUNCTION TO EXCESSIVE TORQUE, HE PULLED IT OUT AND TURNED IT ON. THEN, THE RADIOLUCENT DRIVE TURNED ITSELF TOGETHER WITH THE DRILL BIT. FINALLY, THE DRILL BIT BECAME LOOSE, WAS BLOWN OFF, AND HIT THE WALL IN THE OPERATING ROOM. NO ONE WAS HURT BY THIS INCIDENT, INCLUDING THE PATIENT. THE SURGERY WAS COMPLETED WITH A TWENTY (20) MINUTE DELAY. THERE WERE NO INJURIES, OR NEED FOR ADDITIONAL MEDICAL INTERVENTION REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350608 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM BIT, DRILL HTW SYNTHES SELZACH U243601 07611819775374

    Patients

    Seq Age Sex Outcome Treatment
    1