BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW 40MM

    MDR report key: 6822654 · Received August 25, 2017

    Report

    Report Number
    3009450884-2017-10112
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 27, 2017
    Report Date
    August 4, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    UDI-DI
    07611819003521
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT ID, AGE, & WEIGHT NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODE: KTT. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART #214.040 / LOT #L350369. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 14. MAR. 2017. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SCREW WAS MADE OUT OF BLANK 214.040.999 WITH LOT H217063. AN ADDITIONAL DHR REVIEW TASK WILL BE CREATED FOR THE BLANK. DHR OF BLANK: 214.040.999 WITH LOT H217063. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MOVED TO BLANK STORAGE ON 22-NOV-2016. PART #: 214.040.999, LOT#: H217063 (NON-STERILE) - 4.6MM SCREW BLANK 40MM 04.5 CORTEX SCREW W/3.5 HEX. QUANTITY: (B)(4). COMPONENTS PART 13008 LOT H093502 MEET SPECIFICATION. RAW MATERIAL WAS PROVIDED BY (B)(4) (SUPPLIER LOT: 575851). CERTIFICATE OF TESTS PROVIDED BY (B)(4) MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUT AWAY CHECKLIST MEETS SPECIFICATION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017 DURING FINAL TIGHTENING THE 4.5 CORTICAL SCREW FOR DHS SCREW HEAD FRACTURED OFF THE SHAFT. THE SCREW SHAFT WAS LEFT IN THE PATIENT. THE HEAD WAS REMOVED. NO SURGICAL DELAY IS REPORTED, THE SURGERY WAS COMPLETED AND THE PATIENT DISCHARGED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PART: 1X UNKNOWN SCREWDRIVER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602142 4.5MM CORTEX SCREW 40MM SCREW, FIXATION, BOEN HWC SYNTHES GRENCHEN L350369 07611819003521

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR