BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    MDR report key: 7961280 · Received October 12, 2018

    Report

    Report Number
    8030965-2018-57262
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    September 25, 2018
    Report Date
    September 26, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    10886982067722
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.010.103 , LOT: 9831112 , MANUFACTURING SITE: BETTLACH , RELEASE TO WAREHOUSE DATE: 12.FEB.2016 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND MATERIAL HARDNESS CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. MATERIAL 440A WAS USED WITH CORRECT HARDNESS AFTER PROCEDURE AND DOCUMENTED IN DHR FILE. 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. A PRODUCT INVESTIGATION WAS CONDUCTED. DEVICE CONDITION: THE RETURNED DRILL BIT WAS OBSERVED BROKEN AT ITS TIP. THE BROKEN TIP PORTION WAS NOT RETURNED AS IT IS RETAINED IN THE PATIENT. NO NEW ISSUES WERE IDENTIFIED. THE GIVEN DEVICE CONDITION AGREES WITH THE COMPLAINT CONDITION AND THEREFORE THE COMPLAINT CONDITION WAS CONFIRMED. DRAWING/DOCUMENT SPECIFICATION REVIEW: RELEVANT DRAWINGS FOR THE DEVICE WERE REVIEWED AND NO DESIGN ISSUES WERE NOTED. DIMENSIONAL ANALYSIS PERFORMED ON THE FLUTE DIAMETER AT THE BROKEN SITE MEASURED THE DIAMETER AS 3.0 MM (OM 147) THAT FALLS WITHIN THE DIAMETER PER RELEVANT DRAWING. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER, IT IS LIKELY THAT ANY UNINTENDED EXCESSIVE FORCES DURING USAGE COULD HAVE CONTRIBUTED TO COMPLAINT CONDITION DURING THE INVESTIGATION NO DESIGN/MANUFACTURING ISSUES WERE IDENTIFIED. THEREFORE, 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 · 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN UNKNOWN PROCEDURE. WHILE DISTALLY LOCKING THE HUMERAL NAIL, THE TIP OF THE DRILL BIT BROKE AND THE TIP WAS INSIDE THE PATIENT¿S BONE. IT WAS NOTED THAT THE SURGEON DID NOT REMOVE THE BROKEN TIP OF THE PRODUCT. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS AN UNANTICIPATED X-RAY THAT WAS RELATED TO COMPLAINT. THE SURGEON CONTINUED THE SURGERY AS USUAL. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: HUMERAL NAIL (PART 04.016.240S, LOT 5944349, QUANTITY 1). DISTAL LOCKING SCREW (PART 04.005.420, LOT L713149, QUANTITY 1). DISTAL LOCKING SCREWS (PART 04.005.416, LOT L711509, QUANTITY 2). THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801101 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 03.010.103 9831112 10886982067722

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention