BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM

    MDR report key: 5416590 · Received February 8, 2016

    Report

    Report Number
    2520274-2016-10889
    Event Type
    Injury
    Date Received
    February 8, 2016
    Report Date
    January 22, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK113364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID: (B)(6). ADDITIONAL PRODUCT CODE - HWC. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: 2.7MM LOCKING SCREW (PART # 202.2XX / LOT # UNKNOWN). A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED SINCE NO LOT NUMBER WAS AVAILABLE FOR THE BROKEN DEVICE. ONLY THE HEAD WAS RECEIVED LOCKED INTO THE PLATE (PART #: 249.685 / LOT #: 9152700). THE STAR DRIVE RECESS OF THE RETURNED HEAD IS UNDAMAGED. AN INSPECTION OF THE FRACTURE SITE SHOWS HOMOGENOUS MATERIAL. THE CAUSE OF THE BROKEN SCREW IS UNKNOWN. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED. 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

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR HARDWARE REMOVAL OF A NON-UNION CARPOMETACARPAL (CMC) FUSION. ONE (1) 2.7 MM LOCKING SCREW WAS IDENTIFIED AS HAVING BROKEN POSTOPERATIVELY. DURING THE PROCEDURE THE BROKEN 2.7 MM LOCKING SCREW SHAFT WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THE BROKEN SCREW WAS CONSIDERED BY THE SURGEON TO BE THE CAUSE FOR THE NON-UNION. THERE WAS UNKNOWN SURGICAL DELAY. THE PATIENT¿S STATUS IS REPORTED AS ¿GOOD¿ AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74246 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention