BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6334691 · Received February 15, 2017

    Report

    Report Number
    2520274-2017-10482
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    December 17, 2015
    Report Date
    January 20, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE, CORTEX SCREW. THE FOLLOWING PARTS WERE IMPLANTED IN THE PATIENT BUT IT IS UNKNOWN WHICH PART BROKE: PART NUMBER 400.810, 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM, COMMON NAME¿SCREW, FIXATION, BONE, DEVICE PRODUCT CODE HWC, 510(K) K112583, (B)(4) LOT NUMBER UNKNOWN, AND PART NUMBER 400.811, 1.5MM TI CORTEX SCREW SELF-TAPPING 11MM, COMMON NAME¿SCREW, FIXATION, BONE, DEVICE PRODUCT CODE HWC, 510(K) K112583, (B)(4) LOT NUMBER UNKNOWN. DUE TO THE SCREW BREAKING DURING REMOVAL AND THE SHAFT BEING RETAINED IN THE PATIENT, THIS DEVICE IS NOT CONSIDERED TO HAVE BEEN SUCCESSFULLY EXPLANTED. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE AND SYNTHES MANUFACTURING LOCATION ARE UNKNOWN. 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (UNKNOWN SCREW, PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: OUR INVESTIGATION SHOWS THAT RECEIVED SCREW IS BROKEN AT THE THREADED SHAFT NEARBY SCREW HEAD. THE BROKEN PART IS MISSING. VARIOUS MECHANICAL DAMAGES COULD BE OBSERVED AT CRUCIFORM OF THE SCREW HEAD, SUCH AS SCRATCHES AND WEAR AND TEAR. ALSO, WE FOUND SOME BLOOD RESIDUES ON THE CRUCIFORM'S INNER SURFACE. HOWEVER, BECAUSE OF THE BREAKAGE THIS COMPLAINT IS RATED AS CONFIRMED. NO MANUFACTURING REVIEW COULD BE PERFORMED AS NEITHER ARTICLE NOR LOT NUMBER WAS PROVIDED. BASED ON THE RECEIVED INFORMATION AND WITHOUT MISSING BROKEN PART WE CANNOT DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINED ISSUE. DUE TO THE BREAKAGE AND THE WEAR AND TEAR SIGNS, WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING REMOVAL COULD HAVE LEAD TO THE BREAKAGE. THE MICROSCOPIC VIEW, WITH MAGNIFICATION OF 10X, DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE WHICH CONFIRMS MATERIAL CONFORMITY AS WELL. BECAUSE OF THE DAMAGE AND MISSING BROKEN PART, THE DIMENSIONS WHICH ARE RELEVANT FOR THIS EVENT, CANNOT BE CHECKED. FINALLY WE CONCLUDE, THAT REASON FOR THE DAMAGES IS MOST LIKELY NOT REFERABLE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE RECEIVED INFORMATION AND WITHOUT MISSING BROKEN PART WE CANNOT DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINED ISSUE. DUE TO THE BREAKAGE AND THE WEAR AND TEAR SIGNS, WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING REMOVAL COULD HAVE LEAD TO THE BREAKAGE THE MICROSCOPIC VIEW, WITH MAGNIFICATION OF 10X, DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE WHICH CONFIRMS MATERIAL CONFORMITY AS WELL. BECAUSE OF THE DAMAGE AND MISSING BROKEN PART, THE DIMENSIONS WHICH ARE RELEVANT FOR THIS EVENT, CANNOT BE CHECKED. FINALLY WE CONCLUDE, THAT REASON FOR THE DAMAGES IS MOST LIKELY NOT REFERABLE TO ANY MANUFACTURING NON-CONFORMANCES. 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.

    Description of Event or Problem · 1

    REPORTED THAT DURING A PLANNED REVISION AND HARDWARE REMOVAL SURGERY ON (B)(6) 2015, A CORTEX SCREW HEAD BROKE AND THE SHAFT WAS RETAINED IN THE PATIENT. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2015 WITH AN UNKNOWN PLATE AND AN UNKNOWN QUANTITY OF SCREWS. THE PATIENT WAS SUPPOSED TO HAVE A METACARPAL TRAPEZO PROSTHESIS IN THE FUTURE. THIS WILL BE IMPOSSIBLE BECAUSE THE METACARPAL ROD CANNOT BE MOUNTED BECAUSE OF THE RETAINED SCREW SHAFT. CONCOMITANT MEDICAL PRODUCTS: 1X PLATE (PART AND LOT UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE TYPE OF INSTRUMENT USED TO REMOVE THE SCREW IN NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116922 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN PLATE, QUANTITY 1