BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM

    MDR report key: 8484500 · Received April 4, 2019

    Report

    Report Number
    8030965-2019-62509
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 11, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWE
    UDI-DI
    07611819020665
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE RECEIVED DRILL BIT IS BROKEN APPROXIMATELY 4MM FROM THE FLUTED TIP SECTION. THE TIP AND AS WELL THE CUTTING EDGES ARE IN USED CONDITION. THE RELEVANT FEATURE IS DEFORMED IN A MANNER WHICH PREVENTS ACCURATE MEASUREMENT OF THE FEATURE. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT A MECHANICAL OVERLOADING SITUATION, FOR EXAMPLE METALLIC CONTACT OR LATERAL STRESS, HAS CAUSED THE BREAKAGE. CHECK INSTRUMENTS FOR SOUND SURFACES, AND CORRECT ADJUSTMENT AND FUNCTION. DO NOT USE SEVERELY DAMAGED INSTRUMENTS, INSTRUMENTS WITH UNRECOGNIZABLE MARKINGS, CORROSION, OR BLUNT CUTTING SURFACES. WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE HISTORY LOT , PART: 317.660, LOT: F-25693, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 15.OCT.2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 PROCODES: HTW, DZI, ERL, HBE. DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR A ZYGOMATIC AND ORBITAL BASE FRACTURE. DURING THE PROCEDURE, THE SURGEON WAS FIXING AN UNKNOWN PLATE, AND RECOGNIZED THAT THE DRILL BIT TIP WOULD NOT COME OUT FROM THE PATIENT'S BONE; THE ROTATION OF THE DRILL STOPPED A COUPLE OF TIMES. THEN, THE DRILL BIT TIP BROKE. THE SURGEON REMOVED THE BROKEN FRAGMENTS FROM THE PATIENT'S BONE UNDER X-RAY/IMAGE INTENSIFIER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ABOUT 180 MINUTES (3 HOURS) SURGICAL DELAY REPORTED, HOWEVER, THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES: PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), DRILL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277124 1.5MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE OBERDORF SYNTHES PRODUKTIONS GMBH F-25693 07611819020665

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention