BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L105 TAN

    MDR report key: 4450049 · Received January 26, 2015

    Report

    Report Number
    9612488-2015-10070
    Event Type
    Malfunction
    Date Received
    January 26, 2015
    Date of Event
    January 10, 2015
    Report Date
    January 15, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS NOT IMPLANTED OR EXPLANTED DURING THE PROCEDURE ON (B)(6) 2015. 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

    ADDITIONAL NARRATIVE: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: INVESTIGATION SUMMARY FOR ARTICLE 04.027.036S WITH LOT NUMBER 9240273, 1 PART IS INVOLVED: OUR INVESTIGATION SHOWS THAT THE BLADE IS JAMMED TOGETHER WITH THE IMPACTOR AND THE PROTECT SLEEVE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE RECEIVED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT BECAUSE NO DETAILED INFORMATION ABOUT THE EVENT IS AVAILABLE. AS WE CAN SEE, THE BLADE WAS NOT POSITIONED IN THE PROTECT SLEEVE AS INTENDED. DUE TO THE HAMMERING MARKS AT THE IMPACTOR AND THE SLEEVE, WE CAN PRESUME THAT THE INSTRUMENT WAS SUBJECTED TO AN EXCESSIVE FORCE APPLICATION ONTO THE INCORRECTLY PLACED BLADE WHICH COULD FINALLY CAUSE THE JAMMING AND THE MALFUNCTION OF THE DEVICES. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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: 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 PRODUCT CODE: HWC. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE 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. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE BLADE HAS REMAINED STUCK IN THE PROTECTIVE SLEEVE. IN ADDITION, THE BLADE IS ALSO STUCK ON THE SCREWDRIVER. IT WAS REPORTED THAT IS NOT A REVISION SURGERY. THE DURATION OF THE OPERATION HAS BEEN EXTENDED THE TIME NEEDED TO CHANGE THE BOX, ESTIMATED AT 5 MINUTES. THERE WAS NO PATIENT HARM REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57975 PFNA BLADE PERF L105 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH 9240273

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR