BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 8MM

    MDR report key: 4662291 · Received April 6, 2015

    Report

    Report Number
    3000270450-2015-10081
    Event Type
    Injury
    Date Received
    April 6, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 24, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:WE HAVE RECEIVED ONE SCREW SUBJECT DEVICE (ONE SCREW) HAS BEEN RECEIVED FOR INVESTIGATION AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE SCREW HEAD AND RECESS DO SHOW SLIGHT WEAR MARKS. THE THREADED SHAFT IS BROKEN OFF AND REMAINED IN PATIENT¿S BODY AS REPORTED TO US. EXCEEDING MECHANICAL FORCE CAN LEAD TO TWISTING AND FINALLY TO A BREAKAGE WHICH COULD HAVE BEEN THE CAUSE BY THIS COMPLAINT. SUCH SMALL SCREWS ARE DELICATE TO HANDLE AND PLEASE MAKE SURE TO OPERATE ALWAYS ACCORDING TO THE SURGICAL PROCEDURE IN ORDER TO MINIMIZE SUCH BREAKAGES. THE CAUSE COULD NOT BE DETERMINED EXACTLY. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT DATA IS AVAILABLE. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE SUPPLIER: (B)(4), MANUFACTURING DATE: 20. OCT. 2014, EXPIRY DATE: 01. OCT. 2024. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PART 400.808-EXS LOT 9130394 WERE REVIEWED WITH THE FOLLOWING RESULT: NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. 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. 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A LEFT FIFTH DIGIT PHALANX PROXIMALIS FRACTURE SURGERY, THE SCREW IN QUESTION WAS BROKE RIGHT BELOW THE HEAD WHEN THE SURGEON WAS TIGHTENING IT. THE SCREW HEAD WAS LEFT INSIDE THE PATIENT¿S BODY. THE SURGERY WAS DELAYED FOR 10 MINUTES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226748 1.5MM TI CORTEX SCREW SELF-TAPPING 8MM SCREW, FIXATION, BONE HWC SYNTHES SELZACH 9205839

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention