BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    MDR report key: 3884959 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11743
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    August 20, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE PATIENT WAS (B)(6) OR GREATER AT THE TIME OF SURGERY. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS COMPLAINT WAS PART OF A MARKET PREFERENCE EVALUATION WHICH RECORDS THE COMPLAINT ASPECTS OF 2013 MPE RESULTS. IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2013 ON FOUR RIGHT FRACTURE PLANES AT THE HEAD AND SHAFT BETWEEN THE GREATER AND LESSER TUBEROSITY. THIS PATIENT HAD A DISPLACED VALGUS IMPACTED FRACTURE; THE PATIENT WAS 80 YEARS OLD OR GREATER AT THE TIME OF SURGERY. THERE WAS AN ANATOMIC SURGICAL NECK FRACTURE AND THE CANCELLOUS BONE OF THE HEAD FRAGMENT WAS NOT DEEP ENOUGH TO BE HELD WITH SCREWS PURCHASING BONE 8MM FROM THE SUBCHONDRAL BONE. THERE WAS POOR HANDLING OF THE LENGTH PROBE AND MEASURING OF THE SCREW LENGTH. ALSO, POOR HANDLING AND INJECTION OF THE CONTRAST FLUID THAT LEAKED BACK WHILE BEING INJECTED IN MANY TIMES. BOTH A AND E CANNULATED SCREWS WERE USED BUT CONTRAST PENETRATED INTO THE ANATOMIC NECK FRACTURE LINE FIRST AND THEN INTO THE JOINT SPACE AFTERWARDS. THERE WAS DIFFICULTY FOR POSTERIOR INTERPRETATION OF X-RAYS. NO SCREWS WERE ABLE TO BE CEMENTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361637 DEPTH GAUGE FOR 2.7MM & SMALL SCREWS GAUGE,DEPTH HTJ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1