BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 4958129 · Received July 31, 2015

    Report

    Report Number
    1719045-2015-10491
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 18, 2015
    Report Date
    July 18, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT PROVIDED BY REPORTER. ADDITIONAL PRODUCT CODE: HWC. ORIGINAL IMPLANT DATE UNKNOWN. NOT EXPLANTED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES FOR COMPLAINT NUMBER (B)(4). PART NUMBER: 456.315S, LOT NUMBER: 9825350, RAW MATERIAL NUMBER: 7864203, MANUFACTURE DATE: 06/05/15, EXPIRATION DATE: 2024-04-30, DHR REVIEW DATE: 07/22/15. 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

    THE SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM/INVESTIGATION PROCESS. THE COMPLAINANT PART MALFUNCTIONED DURING THE SURGICAL PROCEDURE AND WAS NOT IMPLANTED OR EXPLANTED. 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

    (B)(4). AN UPDATED MANUFACTURING EVALUATION WAS COMPLETED: THE COMPONENTS ON COMPLAINT WERE RECEIVED DISASSEMBLE AND THE RETAINING CAP WAS MISSING. THE DISASSEMBLED COMPONENTS AND NAIL 456.315 LOT NUMBER 9825350 MATCH THE DRAWING. VERIFIED PARTS WERE CORRECT TO TOP LEVEL ASSEMBLY DRAWING AS WELL AS COMPONENTS: LOCK DRIVER/ LOCK PRONG, 130 DEGREES AND ASSEMBLED PER TOP LEVEL DRAWING. VERIFIED MATERIAL. FUNCTIONAL TESTING CONFIRMED THAT THE LOCKING MECHANISM (COMPONENTS 456.315.2 AND 456.314.3) COULD BE ASSEMBLED AND FULLY ADVANCED WITHIN THE CANNULATION OF THE NAIL (COMPONENT 456.315.1). PER THE DRAWING, THE LOCKING MECHANISM IS SPECIFIED TO BE ADVANCED TO A DEPTH OF 9.5MM +/-0.5. IT WAS CONFIRMED THAT THIS DEPTH COULD BE ACHIEVED BY ADVANCING THE LOCKING MECHANISM TO MAXIMUM CONDITION: 10.00MM. DIMENSIONAL INSPECTIONS COMPLETED WITH CALIBRATED CALIPERS. HOWEVER THE LOCKING CAP HOLDS ALL COMPONENTS IN PLACE AND WAS MISSING. THIS COMPONENT IS PART OF THE PACKAGING AND HOLDS THE LOCKING ASSEMBLY IN PLACE DURING SHIPPING AND HANDLING. ACCORDING TO THE DEVICE HISTORY RECORD DOCUMENTATION THE CAP WAS IN PLACE AT THE TIME OF SHIPMENT ACCORDING TO THE ATTACHED BILL OF MATERIALS (BOM). THIS COMPLAINT IS CONFIRMED AND THE COMPLAINT MATCHES THE RECEIVED CONDITION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: PRODUCT WAS RECEIVED DISASSEMBLE WITH NO DAMAGE TO THE PART OR COMPONENTS. VERIFIED ALL PARTS NAIL AND COMPONENTS (LOCK DRIVER AND LOCK PRONG) WERE CORRECT. HOWEVER, THE LOCKING CAP WAS MISSING. THIS COMPONENT IS A PART OF PACKAGING AND HOLDS THE ASSEMBLY IN PLACE. ACCORDING TO THE PACKAGING BILL OF MATERIALS (BOM), THIS COMPONENT WAS IN PLACE AT THE TIME OF SHIPMENT. VERIFICATION OF MATERIAL PASSED. 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 DURING A TROCHANTERIC NAIL INSERTION, UPON OPENING THE 170 MM TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, PART NUMBER 456.315S, LOT NUMBER 9825350, THE LOCKING MECHANISM FELL OUT OF THE NAIL. ANOTHER IMPLANT WAS IMMEDIATELY AVAILABLE. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501210 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9825350

    Patients

    Seq Age Sex Outcome Treatment
    1