BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION

    MDR report key: 7742645 · Received August 2, 2018

    Report

    Report Number
    8030965-2018-55440
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    July 18, 2018
    Report Date
    July 18, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819796973
    PMA / PMN Number
    EXEMPT
    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. PART: 324.210; LOT: L123163; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: SEPTEMBER 09, 2016 THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE USED MATERIAL WAS STAINLESS STEEL 440A AS REQUIRED AND THE MEASURED HARNESS WAS WITH 53.5 ¿ 54.5 HRC WITHIN THE SPECIFICATION OF 52 0/+3 HRC. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SITE: CQ ZUCHWIL; SELECTED FLOW: 5. BROKEN VISUAL INSPECTION: THE INVESTIGATION HAS SHOWN THAT THE TIP OF THE SCREWDRIVER IS BROKEN OFF AS COMPLAINED - APPROXIMATELY 65MM OF THE TIP ARE MISSING. THE BROKEN OFF TIP WAS NOT RETURNED FOR INVESTIGATION. DIMENSIONAL INSPECTION: SHAFT DIAMETER WAS MEASURED JUST BELOW THE BROKEN AREA. DIAMETER IS 2.44MM WHICH COMPLIES WITH THE SPECIFICATIONS (2.45MM 0/-0.3MM, GAGE 3-01-17584). FURTHER DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DAMAGE INCURRED. DRAWING/SPECIFICATION REVIEW: NOT REQUIRED PER SELECTED INVESTIGATION FLOW AS IT CONCERNS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE OF THE DEVICE. MATERIAL /HARDNESS REVIEW: THIS INSTRUMENT IS MADE OF STAINLESS STEEL (440A). ACCORDING TO THE RELEVANT TEST INSTRUCTION, THE CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATION OF 52-55HRC. SUMMARY THE COMPLAINT CONDITION IS CONFIRMED AS THE CUTTING TIP IS BROKEN OFF. THIS PRODUCTION LOT (L123163) WAS MANUFACTURED IN SEPT 2016 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE REVIEW HAS SHOWN THAT THE HARDNESS WAS WITHIN THE SPECIFICATION OF 52-55HRC. MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO COMPLY WITH THE SPECIFICATIONS. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE BREAKAGE, IT IS MOST LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO EXCESSIVE FORCE/STRAIN. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER EMAIL ADDRESS IS UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORDS REVIEW 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN OPEN REDUCTION INTERNAL FIXATION WITH LCP SYSTEM WAS APPLIED TO PELVIS FRACTURES ON (B)(6) 2018. WHEN THE SURGEON DRILLED THE BONE WITH THE DRILL BIT, THE DRILL BIT BROKE. THE SAME THING OCCURRED WHEN USING A SECOND DRILL BIT. SINCE THE LOCATION OF THE DEVICE FRAGMENTS WERE DEEP FROM THE BODY SURFACE, THE SURGEON DECIDED TO LEAVE THEM INSIDE THE BONE. SURGERY CONTINUED, AND THE IMPLANTS WERE PLACED. THE SURGEON COMMENTED THAT IT IS UNKNOWN IF THERE WILL BE ADVERSE CONSEQUENCE TO THE PATIENT IN THE FUTURE DUE TO THE REMAINING PIECES OF THE DRILL BITS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT IS CURRENTLY IN THE HOSPITAL. NO REOPERATION IS SCHEDULED, BUT THE PATIENT WILL BE MONITORED. THE SURGEON NOTED THAT IT WAS VERY HARD TO DRILL THE BONE USING THE AFFECTED DRILL BITS. THIS REPORT IS FOR A 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585448 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH L123163 07611819796973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention