BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 42MM-STERILE

    MDR report key: 6565197 · Received May 12, 2017

    Report

    Report Number
    3000270450-2017-10166
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    April 15, 2017
    Report Date
    April 17, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT AVAILABLE FOR REPORTING (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLAINED CORTEX SCREW SHOWS THAT THE SCREW HEAD IS INDEED BROKEN OFF. THE ANODIZED COLOR ON THE SCREW IS PARTLY ABRADED AND THE HEX AT THE SCREW HEAD SHOWS SIGNS OF USAGE. FURTHERMORE THE THREAD FLANKS, CLOSE TO THE SCREW HEAD, ARE ROUNDED AND WORN. AS THE LOT NUMBER WAS NOT PROVIDED WE CANNOT DETERMINE WHEN THIS SCREW WAS MANUFACTURED. THE EVENT DESCRIPTION DESCRIBES THAT THE SURGEON HASN'T USED A TORQUE LIMITER FOR THE FINAL TIGHTENING. THEREFORE IT IS LIKELY THAT A MECHANICAL OVERLOADING SITUATION (BY NOT USING A TORQUE LIMITER) WAS MOST PROBABLY THE REASON FOR THE BREAKAGE. PER THE SURGICAL TECHNIQUE GUIDE: WHEN INSERTING SCREWS UNDER POWER, FINAL TIGHTENING SHOULD BE DONE USING MANUAL SCREWDRIVER AND TORQUE LIMITER. BASED ON THESE FINDINGS, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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

    THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 IS REPORTED DURING A PROCEDURE TO IMPLANT A VARIABLE ANGLE DISTAL HUMERUS PLATE (VA DHP) PLATE FOR A DISTAL HUMERUS FRACTURE ON (B)(6) 2017, THE HEAD OF ONE OF THE VA LOCKING SCREWS BROKE WHEN SURGEON WAS INSERTING IT INTO THE PLATE HOLE. SURGEON SUSPECTS THE SCREW BROKE DUE TO EXCESSIVE FORCE CAUSED BY NOT USING THE TORQUE LIMITING ATTACHMENT DURING FIXATION. THE FRAGMENT WAS RETRIEVED. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES WHILE THE FRAGMENT WAS RETRIEVED. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. CONCOMITANT DEVICES REPORTED: VA DHP PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346500 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 42MM-STERILE SCREW,FIXATION,BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR