BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 5685671 · Received May 27, 2016

    Report

    Report Number
    9612488-2016-10251
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 13, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 04 FEBRUARY 2016, EXPIRY DATE: 01 JANUARY 2026, 04.503.104.04S / 9812600. 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. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: NON-STERILE 72563 / 9907824 WERE MANUFACTURED IN (B)(4), MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28-SEP-2015, PART #: 04.503.104.20, LOT#: 9907824 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. QUANTITY (B)(4). LOT WAS RELEASE TO THE WAREHOUSE ON 28-SEP-2015. 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. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION:(B)(4), MANUFACTURING DATE: 05-OCT-2015, PART #: 04.503.104.10, LOT#: 9907824 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. 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. 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. (B)(6). PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. SINCE COMPLAINED CONDITION WAS DISCOVERED DURING A SURGICAL PROCEDURE AND EVEN THOUGH THE BREAKAGE OCCURRED PRIOR TO USE, THIS IS STILL CONSIDERED AN EVENT WITH PATIENT INVOLVEMENT. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 THE SURGERY ON (B)(6) 2016, A NURSE FOUND THAT THE SLOT OF THE REPORTED SCREW HEAD WAS BROKEN BEFORE USING. THEN, THE NURSE USED NEW SCREWS (THE SAME SPECIFICATION AS THE REPORTED SCREW) FROM OTHER PACKAGE ON THE SURGERY. NO SURGICAL DELAY WAS REPORTED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR COM- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340364 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C SCREW, FIXATION, BONE HWC SYNTHES BETTLACH 9812600

    Patients

    Seq Age Sex Outcome Treatment
    1