BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE

    MDR report key: 7326616 · Received March 9, 2018

    Report

    Report Number
    8030965-2018-51877
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Report Date
    February 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819274112
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 310.509, SYNTHES LOT NUMBER: 2824829: RELEASE TO WAREHOUSE DATE: 22.DEZ.2011, MANUFACTURING SITE: BETTLACH: NO NON-CONFORMANCE REPORTS (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. H3, H6: A PRODUCT INVESTIGATION WAS PERFORMED. WE HAVE RECEIVED A DRILL BIT FOR INVESTIGATION. THE VISUAL INSPECTION HAS SHOWN THAT APPROXIMATELY 6 MM FROM THE FLUTED TIP SECTION IS BROKEN OFF. THE BROKEN TIP WAS NOT RETURNED FOR EVALUATION. FURTHER INVESTIGATION HAS SHOWN THAT THE FLUTES ARE UNTWISTED AND THE TWO BLADES ARE WORN. THE MEASUREMENTS OF THE HARDNESS AFTER THE HARDENING PROCEDURE WERE WITHIN THE SPECIFICATION. THE USED MATERIAL WAS STAINLESS STEEL 440 A AS REQUIRED. BASED ON THESE FINDINGS WE EXCLUDE ANY MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS BREAKAGE. WE ONLY CAN ASSUME THAT A MECHANICAL OVERLOADING SITUATION, FOR EXAMPLE METALLIC CONTACT OR LATERAL STRESS, HAS CAUSED THE BREAKAGE. MEASUREMENT OF OUTER DIAMETER WAS DONE PER RELEVANT DRAWING AND IS WITHIN THE SPECIFICATION. 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

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO KNOWN PATIENT INVOLVEMENT. DATE OF BREAKAGE IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HAS ARRIVED FOR INVESTIGATION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 FROM THE LOAN SET DEPARTMENT, THAT DURING INSPECTION OF THE ORTHO KIT A SPECIALIST FOUND TWO BROKEN DRILL BITS. THE BROKEN FRAGMENTS WERE NOT RETURNED. NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170534 DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 2824829 07611819274112

    Patients

    Seq Age Sex Outcome Treatment
    1