BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/20MM

    MDR report key: 5921588 · Received September 1, 2016

    Report

    Report Number
    1719045-2016-10653
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Report Date
    August 17, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THIS COMPLAINT IS CONFIRMED. RETURNED INTACT PLATE, TWO CORTEX AND TWO LOCKING SCREWS DO SHOW SLIGHT MARKS OF USE. DHR-REVIEW FOR PLATE AND CORTEX SCREWS CONDUCTED AND NO DEVIATION FOUND. ALL 5 RETURNED BUTTRESS PINS ARE BROKEN. THE BREAK IS JUST BELOW THE HEAD ON EACH RETURNED PIN. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE AS THE RETURNED PINS ARE ALREADY BROKEN. CROSS SECTION MEASUREMENTS AT THE AREA OF BREAKAGE WERE TAKEN AT CUSTOMER QUALITY (CQ) USING MICROMETERS OM521 FOR EACH RETURNED PIN. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, 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 NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONALLY, THE CALCULATED OCCURRENCE RATE IS ACCEPTABLE WITH THE APPLICABLE DESIGN AND CLINICAL RISK MANAGEMENT OCCURRENCE RATE. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 1ST DECEMBER 2012, EXPIRY DATE: 1ST NOVEMBER 2022, ARTICLE WAS STERILIZED BY SUPPLIER (B)(4) WITH LOT NUMBER 8182550, ARTICLE 04.210.090 WAS MANUFACTURED IN THE US WITH LOT NUMBER 6830691. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. ARTICLE WAS STERILIZED BY SUPPLIER FRÜH WITH LOT NUMBER 8182550. ARTICLE 04.210.090 WAS MANUFACTURED IN THE US WITH LOT NUMBER 6830691.PART #: 04.210.090, LOT#: 6830691 (NON-STERILE) - 1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/20MM. MANUFACTURING DATE: (B)(6) THERE WERE NO NONCONFORMANCES 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT SOMETIME IN (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR DISTAL RADIUS FRACTURE. ON (B)(6) 2016, DURING A NAIL EXTRACTION SURGERY; IT WAS FOUND THAT FIVE (5) PINS WERE BROKEN. THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT'S BODY; DATE OF THE PINS BREAKING IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH FIFTEEN (15) MINUTES DELAY. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574391 1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/20MM PLATE,FIXATION,BONE HRS SYNTHES MONUMENT 8182550

    Patients

    Seq Age Sex Outcome Treatment
    1