BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP

    MDR report key: 6976534 · Received October 25, 2017

    Report

    Report Number
    3000270450-2017-10376
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 3, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    UDI-DI
    07611819775381
    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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER U243062. MANUFACTURING LOCATION: (B)(4). SUPPLIER: EXTERNAL SUPPLIER (B)(4). MANUFACTURING DATE: 08.APR.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. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP, PART NUMBER 03.010.101, LOT NUMBER U243062). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING: DRILL BIT RECEIVED UNPACKED WITH TRACES OF USE. TWO MEASUREMENTS WERE TAKEN Ø4.2 AND Ø7.94. BOTH CONFORMED TO THE VALID DRAWING AND MANUFACTURING ORDER. VISUAL INSPECTION DID SHOW THAT THE SHAFT AND CUTTING FRONT SECTION DO HAVE MARKS OF USE. THE PLASTIC END PIECE IS STILL IN POSITION AND MOUNTED ON THE SHAFT LIKE IT WAS DELIVERED FROM MANUFACTURING. FURTHER THERE IS SOME BLACK GREASE ADHERED TO THIS PLASTIC PIECE WHICH MUST BE COMING FROM THE POWER TOOL USED. THE COMPLAINED (SPINNING VERY ECCENTRICALLY) COULD NOT BE CONFIRMED. BASED ON MEASUREMENTS TAKEN, VISUAL EXAMINATION, DHR-CHECK NO MANUFACTURING RELATED FAILURE COULD BE DETECTED AND COMPLAINED ISSUE COULD NOT BE CONFIRMED. THE EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. 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 USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID, DOB & WEIGHT NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED IN THE SURGERY FOR THE TIBIAL DIAPHYSIS FRACTURE ON (B)(6) 2017. THE EXTERNAL TIBIAL NAIL WAS USED FOR THE PROCEDURE. WHEN THE SURGEON TRIED TO PLACE THE DISTAL LOCKING, IT WAS FOUND THAT THE (FIRST) DRILL BIT IN WAS SPINNING VERY ECCENTRICALLY. WHEN ANOTHER (SECOND) DRILL BIT WAS USED, IT WAS STILL SPINNING ECCENTRICALLY, BUT LESS THAN THE FIRST DRILL BIT; THUS, THE SURGEON DECIDED TO USE THE SECOND DRILL BIT. SINCE THE PATIENT WAS A MALE, IN HIS 30S, AND WELL-BUILT, THE SURGEON HAD A DIFFICULTY IN DRILLING THE BONE. THE ROTATION SPEED OF THE DRILL BIT IN QUESTION DECREASED BEFORE REACHING THE CONTRALATERAL SIDE OF THE CORTEX BONE. BECAUSE THE SURGEON FELT SOMETHING WRONG WITH THE ROTATION SOUND OF THE DRILL BIT IN QUESTION, THE OTHER DRILL BIT (QUICK TYPE, 4.2MM) WAS USED EVENTUALLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS EXTENDED FOR 10 MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT DEVICE: 1X UNK EXTERNAL TIBIAL NAIL. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756273 DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP BIT,DRILL HTW SYNTHES SELZACH U243062 07611819775381

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR