BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    MDR report key: 6218503 · Received January 3, 2017

    Report

    Report Number
    9612488-2017-10003
    Event Type
    Injury
    Date Received
    January 3, 2017
    Date of Event
    December 6, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    UDI-DI
    07611819760899
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE USED FSM. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.061, LOT# L000580. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUN 24, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: THE DRILL BIT IS BROKEN AS DESCRIBED IN THE COMPLAINT DESCRIPTION. THE BROKEN TIP PART, APPROXIMATELY 10 MM, IS MISSING. THERE ARE DIFFERENT NICKS AND STRIATION SIGNS ALONG THE FLUTE. OUR INVESTIGATION SHOWS THAT THE DRILL BIT IS BROKEN AS DESCRIBED IN THE COMPLAINT DESCRIPTION. BECAUSE OF THE BREAKAGE THIS COMPLAINT IS RATED AS CONFIRMED. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AS INDICATED IN THE MANUFACTURING DOCUMENTS THE CORRECT MATERIAL (440A) WAS USED AND THE HARDNESS WAS IN SPECIFICATION. THE MICROSCOPIC VIEW, WITH A MAGNIFICATION OF 10X, OF THE BROKEN SURFACE SHOWS A HOMOGENOUS SURFACE WHAT INDICATES MATERIAL CONFORMITY. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE DUE TO MISSING DETAILED CLINICAL INFORMATION AND MISSING BROKEN PART. IT IS LIKELY THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED. 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 DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, THE DRILL BIT BROKE DURING THE SURGERY, AND REMAINED INSIDE THE PATIENT THROUGH THE NAIL IN THE CANAL. THE SURGEON DECIDED NOT TO REMOVE THE PRODUCT. NO PROLONGATION OF THE SURGERY WAS REPORTED. PATIENT OUTCOME REPORTED AS STABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT PART: NAIL (PART# 04.013.448, QUANTITY 1). THIS REPORT IS FOR ONE (1) THREE FLUTED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    AS PER VISUAL INSPECTION ONLY THE TIP BROKE OFF FROM THE DEVICE AND REMAINED IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION BIT, DRILL HTW SYNTHES BETTLACH L000580 07611819760899

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART# 04.013.448, LOT # UNKNOWN, QUANTITY 1