BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BOLT FOR 2.0MM SCREWS

    MDR report key: 10357281 · Received August 3, 2020

    Report

    Report Number
    8030965-2020-05564
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Report Date
    July 11, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819018310
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: PART: 309.190; LOT: 9001467; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 23.AUGUST 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: A PORTION OF THE TIP OF THE EXTRACTION BOLT IS BROKEN OFF AS COMPLAINED. THE BROKEN OFF FRAGMENT WAS NOT RETURNED FOR INVESTIGATION. BESIDES, THE INSTRUMENT PRESENTS NORMAL SIGNS OF USE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW: THE REVIEW HAS SHOWN THAT WITH 1.4112 STAINLESS STEEL THE CORRECT MATERIAL WAS USED, AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS A PORTION OF THE TIP OF THE EXTRACTION BOLT IS BROKEN. THIS PRODUCTION LOT (9001467) WAS MANUFACTURED IN AUGUST 2014 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 CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATIONS. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIAS. BASED ON THE PROVIDED INFORMATION ¿ DAMAGE NOTED DURING LOAN KIT INSPECTION - WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. HOWEVER, THE DAMAGE APPEARS TO BE THE RESULT OF HIGH APPLIED FORCES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 ON AN UNKNOWN DATE BY THE LOAN KIT TECHNICIAN DURING A LOAN KIT INSPECTION THAT THE EXTRACTING END OF THE CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREW AND THE EXTRACTION BOLT FOR 2.0MM SCREWS HAVE SNAPPED OFF. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 2.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820660 EXTRACTION BOLT FOR 2.0MM SCREWS EXTRACTOR HWB OBERDORF SYNTHES PRODUKTIONS GMBH 9001467 07611819018310

    Patients

    Seq Age Sex Outcome Treatment
    1