BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5730271 · Received June 16, 2016

    Report

    Report Number
    2520274-2016-13197
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 1, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION WAS RECEIVED ON JUN 27, 2016 REGARDING PART NUMBERS AND QUANTITIES OF EACH IMPLANTED IN THE PATIENT. FOUR PART NUMBERS CORRESPOND TO THE REPORTED 4.5MM CORTICAL SCREWS WHICH HAD BROKEN. IT IS UNKNOWN HOWEVER, WHICH OF THESE PART NUMBERS AND HOW MANY OF EACH HAD BROKEN. THE REPORTED PARTS AND ASSOCIATED INFORMATION IS AS FOLLOWS: PART NUMBER 214.834, BRAND NAME 4.5MM CORTEX SCREW SELF-TAPPING 34MM, DEVICE PRODUCT CODE¿HWC, COMMON NAME¿SCREW, FIXATION, BONE; 510(K) K112583, QUANTITY 1 INITIALLY IMPLANTED IN PATIENT. OTHER NUMBER¿UDI: (B)(4)LOT NUMBER UNKNOWN. PART NUMBER 214.836, BRAND NAME 4.5MM CORTEX SCREW SELF-TAPPING 36MM, DEVICE PRODUCT CODE¿HWC, COMMON NAME¿SCREW, FIXATION, BONE; 510(K) K112583, QUANTITY 3 INITIALLY IMPLANTED IN PATIENT. OTHER NUMBER¿UDI: (B)(4) LOT NUMBER UNKNOWN. PART NUMBER 214.838, BRAND NAME 4.5MM CORTEX SCREW SELF-TAPPING 38MM, DEVICE PRODUCT CODE¿HWC, COMMON NAME¿SCREW, FIXATION, BONE; 510(K) K112583, QUANTITY 1 INITIALLY IMPLANTED IN PATIENT. OTHER NUMBER¿UDI: (B)(4) LOT NUMBER UNKNOWN. PART NUMBER 214.842, BRAND NAME 4.5MM CORTEX SCREW SELF-TAPPING 42MM, DEVICE PRODUCT CODE¿HWC, COMMON NAME¿SCREW, FIXATION, BONE; 510(K) K112583, QUANTITY 1 INITIALLY IMPLANTED IN PATIENT. OTHER NUMBER¿UDI: (B)(4) LOT NUMBER UNKNOWN. THE COMPLAINED DEVICES WERE REPORTEDLY DISCARDED BY THE REPORTING FACILITY. 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

    THIS REPORT IS FOR FOUR UNKNOWN 4.5MM CORTICAL SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE A REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) PROXIMAL FEMUR PROCEDURE WAS PERFORMED ON THE (B)(6) 2016. PATIENT HAD BEEN IMPLANTED WITH A PROXIMAL FEMORAL PLATE FOR A SUBTROCHANTERIC FRACTURE ON (B)(6) 2016. PATIENT HAD BEEN WEIGHT BEARING ON A ZIMMER FRAME. THE FRACTURE DID NOT UNITE RESULTING IN BREAKAGE OF FOUR, 4.5MM CORTICAL SCREWS. DURING THE REVISION SURGERY A LONGER PROXIMAL FEMORAL PLATE WAS IMPLANTED ALONG WITH A LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) STRAIGHT PLATE. THE REVISION SURGERY WENT WELL. A STRONGER CONSTRUCT WAS USED. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE: UNKNOWN PLATE THIS REPORT IS FOR FOUR UNKNOWN 4.5MM CORTICAL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383973 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention