BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UHN Ø6.7 L220 TAN VIOL

    MDR report key: 5150269 · Received October 14, 2015

    Report

    Report Number
    3009417901-2015-10026
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 29, 2015
    Report Date
    October 1, 2015
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER: (B)(6). INITIAL REPORTER: PHONE NUMBER: (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. EVENT DATE: (B)(6) 2015 IS THE CORRECT DATE OF EVENT. IMPLANT AND EXPLANT DATES: DEVICE WAS NOT IMPLANTED/EXPLANTED. 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

    X-RAY TAKEN ON AN UNKNOWN DATE. MANUFACTURING INVESTIGATION EVALUATION: THE COMPLAINED NAIL WAS FORWARDED TO THE RESPONSIBLE MANUFACTURING SITE FOR EVALUATION. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS SOLID HUMERAL NAIL WAS MANUFACTURED IN JUNE, 2015 IN ACCORDANCE WITH ALL ESTABLISHED REQUIREMENTS AND NO NON- CONFORMITIES REPORTED. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE DIAMETER WAS MEASURED AND IS ACCORDING SPECIFICATION. THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DETERMINED. THE VISUAL INSPECTION CONFIRMED THE COMPLAINT CATEGORY OF BROKEN ALTHOUGH THE EXACT CAUSE OF THE BREAKAGE IS UNKNOWN. THE RECEIVED X-RAY WAS RETURNED. HOWEVER, THE REVIEW OF THE IMAGE DID NOT ASSIST IN CONFIRMING THE COMPLAINT DESCRIPTION AS IT WAS LIKELY A PREOPERATIVE IMAGE. NO PRODUCT FAULT WAS DETECTED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT PROVIDED BY REPORTER. EVENT DATE: UNKNOWN EXACTLY WHEN NAIL BROKE. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 05 JUNE 2015, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGICAL PROCEDURE WAS PERFORMED SMOOTHLY TO THE POINT WHICH IS TO MAKE THE DISTAL LOCKING OF THE NAIL; WHEN THE POSITION OF THE NAIL AND THE SITUATION OF LOCKING HOLES ARE VERIFIED, IT APPEARS THAT THE NAIL LOOKS STRANGE. THE NAIL IS REMOVED AND AT THE TIME OF EXTRACTING IS PART PENULTIMATE LEVEL DISTAL LOCKING. BECAUSE OF THIS, A NAIL OF THE SAME LENGTH BUT OF GREATER DIAMETER IS USED. SURGERY IS COMPLETED AND PERFORMING A LOCKING PROXIMAL AND ONE DISTAL. THE SURGEON SEEN THAT THE NAIL APPEARED STRANGE IN FORM, SO HE DECIDES REMOVED THE NAIL. WHEN THE SURGEON REMOVED THE NAIL, HE CAN SEE THAT THE NAIL IS BROKEN . PINCERS WERE USED, AND AN OPENING WAS REAMED IN THE HUMERUS. A UHN WAS INSERTED, WHICH BROKE WHILE ATTEMPTING TO INSERT IT. IN A SECOND ATTEMPT, ANOTHER UHN WAS INSERTED, AS FOR THE REDUCTION, A SMALLER ONE WAS NECESSARY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679778 UHN Ø6.7 L220 TAN VIOL SCREW, FIXATION, BONE HWC SYNTHES SALZBURG 5934483

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR