BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

    MDR report key: 3180838 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03745
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    March 26, 2012
    Report Date
    March 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE VISUAL INVESTIGATION OF THE COMPLAINED SCREW HAS SHOWN THAT THE TIP IS NOT BROKEN AS COMPLAINED. WE FOUND THAT THE TIP IS BADLY DEFORMED DUE TO MECHANICAL OVERLOADING. MICROSCOPIC EVALUATION SHOWS THAT THE TIP OF THE SCREW IS FLATTENED, IT APPEARS THAT THE TIPS GOT DAMAGED DURING INSERTION INTO VERY HARD BONE. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENTS SHOW NO DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE. (B)(6).

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DATE OF THIS REPORT: AWARENESS DATE REPORTED INCORRECTLY IN INITIAL MW. MFG DATE: DATE RECEIVED BY MANUFACTURER REPORTED INCORRECTLY IN INITIAL MW; DATE IS 03/28/2012.

    Description of Event or Problem · 1

    TIP OF SCREW WAS BROKEN. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279612 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C JEY SYNTHES GMBH 2772211

    Patients

    Seq Age Sex Outcome Treatment
    1