BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM TI MULTILOC HUMERAL NAILLEFT/CANN/225MM-

    MDR report key: 8934746 · Received August 27, 2019

    Report

    Report Number
    8030965-2019-67749
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819501195
    PMA / PMN Number
    K120807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INVESTIGATION: THE RECEIVED HUMERAL NAIL MULTILOC Ø7 IZQ CAN L225 TAN SHOWS A STRONG DEFORMATION ON THE COUPLING FOR THE AIMING ARM. A SIDE WALL IS SEVERELY DEFORMED AND CRACKED. NOTHING IS BROKEN OFF AS REPORTED IN THE EVENT DESCRIPTION. DIMENSIONAL INSPECTION: A DIMENSIONAL TEST IS NOT APPROPRIATE, SINCE ALL COMPLAINT-RELEVANT DIMENSIONS CAN NO LONGER CORRESPOND TO THE VALID TECHNICAL DRAWINGS SPECIFICATIONS DUE TO THE DAMAGE INCURRED. DOCUMENT / SPECIFICATION REVIEW: SURGICAL TECHNIQUE FOR MULTILOC HUMERAL NAILING SYSTEM REVIEWED FOR CORRECT NAIL INSERTION HANDLING. INVESTIGATION CONCLUSION: IT WAS REPORTED THAT THE HEAD OF SCREW WAS BROKEN OFF DURING AN UNKNOWN SURGERY. THE COMPLAINT CANNOT BE CONFIRMED AS WE RECEIVED A HUMERAL NAIL MULTILOC Ø7 IZQ CAN L225 TAN WITH A DEFORMED COUPLING BUT WITHOUT BROKEN OFF PARTS OR FRAGMENTS. THE NAIL PROXIMAL DAMAGE OCCURRED MOST LIKELY DURING THE INSERTION OF THE NAIL INTRAOPERATIVELY. BECAUSE OF THE VERY POOR EVENT INFORMATION RECEIVED, WE DO SUPPOSE THAT THE SELECTED NAIL DIAMETER WAS TOO LARGE, RESULTING IN HIGHER INSERTION RESISTANCE. ACCORDING THE SURGICAL TECHNIQUE DSEM!TRM/0115/0301 (2) 03/16, TWO ALTERNATIVES ARE POSSIBLE: CHOOSE A SMALLER DIAMETER NAIL OR REAM THE INTRAMEDULLARY CANAL TO A LARGER DIAMETER. WE ARE NOT ABLE TO DETERMINE AN EXACT CAUSE OF DAMAGE, BUT WE SUPPOSE THAT NONCOMPLIANCE WITH SURGICAL TECHNIQUE AND EXCESSIVE APPLICATION OF FORCE LED TO THIS ISSUE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 04.017.225S, LOT: 5937109, MANUFACTURING SITE: SALZBURG, RELEASE TO WAREHOUSE DATE: 22. DECEMBER 2015, EXPIRY DATE: 01. DECEMBER 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DATE REC¿D BY MFR : THE INCORRECT DATE WAS INADVERTENTLY UTILIZED IN INITIAL MEDWATCH. THE CORRECT DATE IS AUGUST 13, 2019.  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 · 0

    UPDATED EVENT DESCRIPTION: DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) TO TREAT HUMERUS FRACTURE, A 7MM TI MULTILOC HUMERAL NAIL LEFT BROKE. ALL THE BROKEN PIECES WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY TIME WAS NOT DELAYED. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) 7MM TI MULTILOC HUMERAL NAIL LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE UNKNOWN SURGERY, THE HEAD OF SCREW WAS BROKEN OFF. ALL THE BROKEN PIECES WOULD BE RETURNED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY TIME WAS NOT DELAYED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) 7MM TI MULTILOC HUMERAL NAILLEFT/CANN/225MM-STERILE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731545 7MM TI MULTILOC HUMERAL NAILLEFT/CANN/225MM- ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 5937109 07611819501195

    Patients

    Seq Age Sex Outcome Treatment
    1