BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI METAPHYSEAL SCREW SLF-TPNG/T8 STRDRV/36MM-ST

    MDR report key: 5513899 · Received March 21, 2016

    Report

    Report Number
    3000270450-2016-10071
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    February 24, 2016
    Report Date
    February 26, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PK120854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT FULLY IMPLANTED OR EXPLANTED. DEVICE 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

    (B)(4). THIS EVENT RESULTED IN A RETAINED FRAGMENT. NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 15 JANUARY 2013 EXPIRY DATE: 01 JANUARY 2023 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE (B)(4) WERE MANUFACTURED IN US, (B)(4) A DHR REVIEW WAS PERFORMED FOR: PART NUMBER: 01.118.536, SYNTHES LOT NUMBER: 7062660, REVIEW LOCATION: (B)(4) MANUFACTURE DATES: 11/06/12. THE REVIEW OF THE DHR SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMANCES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WAS ONE NCR THAT IS INCLUDED IN THE DHR (B)(4)). 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 ITALY AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY OF A (B)(6) MALE PATIENT, WHEN THE SURGEON TRIED TO INSERT TWO SCREWS INTO THE BONE THE SCREWS BROKE OFF. A BROKEN SCREW HAS REMAINED WITHIN THE PATIENT AND THE OTHER ONE HAS BEEN REMOVED. THE SURGEON USED A CORTICAL SCREW IN PLACE OF THE REMOVED SCREW. THE SURGERY WAS PROLONGED ABOUT 20 MINS. NO CONSEQUENCES FOR THE PATIENT. THIS COMPLAINT INVOLVES 2 PART. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169474 2.7MM TI METAPHYSEAL SCREW SLF-TPNG/T8 STRDRV/36MM-ST SCREW, FIXATION, BONE HWC SYNTHES SELZACH 8235128

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention