BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

    MDR report key: 4781631 · Received May 19, 2015

    Report

    Report Number
    2520274-2015-13973
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    DZI
    PMA / PMN Number
    PK082649
    Adverse Event
    Yes
    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. ADDITIONAL DEVICE PRODUCT CODE¿DZJ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: THE 510K#: K082649 DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 06.JAN.2014, 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE TIP IS BROKEN OFF DUE TO MECHANICAL OVERLOADING DURING USE. THE MEASURED DIMENSION OF THE SHAFT IS 1.50MM WHICH MEETS EXACTLY TO THE SPECIFIED RANGE OF DRAWING. REVIEWING OF THE MANUFACTURING DOCUMENTS SHOWS THAT THE PART WAS MADE FROM MATERIAL 1.4112. THE DHR REVIEW AND MEASURING OF DIMENSION SHOWS CONFORMITY TO THE SPECIFICATION. THIS PART WAS MANUFACTURED ACCORDING TO OUR VALID SPECIFICATION, THEREFORE, NO INDICATION FOR MATERIAL OR DESIGN RELATED ISSUE WAS FOUND. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO TREAT A JAW DEFORMITY ON (B)(6), 2015, THE DRILL TIP BROKE. THE SURGEON STARTED DRILLING USING THE COMPLAINED DRILL BIT WITH A CONTRA-ANGLE DRIVER. THE DRILL TIP BROKE WHEN HE WAS DRILLING THE 12TH HOLE. HE COULD NOT RETRIEVE THE BROKEN TIP SO IT REMAINS INSIDE THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED WITH A DELAY; HOWEVER, THE SPECIFIC LENGTH OF THE DELAY IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327106 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES SELZACH F-14998

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention