BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 6678671 · Received June 29, 2017

    Report

    Report Number
    2530088-2017-10216
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Report Date
    June 5, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    UDI-DI
    10886982196088
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    DHR REVIEW FOR PART # 357.377, SUPPLIER LOT # 4910197. RELEASE TO WAREHOUSE DATE: 06-JUL-2005. EXPIRATION DATE: NA. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS 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

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICE (PART 357.372) WAS NOT RECEIVED AT THE INVESTIGATION CENTER FOR EVALUATION. THE DEVICE (PART 357.377) WAS RECEIVED BROKEN; THE WELD THAT SECURED THE PROXIMAL KNOB HAS BROKEN AND THE KNOB IS ABLE TO BE UNSCREWED AND REMOVED FROM THE DEVICE SHAFT. THE COMPLAINT DEVICES ARE REUSABLE INSTRUMENTS AVAILABLE IN THE TROCHANTERIC FIXATION NAIL (TFN) SYSTEM AND USED TO AID IN HELICAL BLADE INSERTION. THE RELEVANT DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE COMPLAINT CONDITION FOR THE RECEIVED PART WAS MOST LIKELY DUE TO CUMULATIVE WEAR FOR THIS 12 YEAR OLD REUSABLE INSTRUMENT THAT IS HAMMERED ON BY TECHNIQUE TO INSERT HELICAL BLADES. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART 357.377, LOT 4910197: RELEASE TO WAREHOUSE DATE: 06-JUL-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO (2) TFN (TROCHANTERIC FEMORAL NAIL) INSTRUMENTS, HELICAL BLADE INSERTER AND HELICAL BLADE COUPLING SCREW WERE FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458472 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4910197 10886982196088

    Patients

    Seq Age Sex Outcome Treatment
    1