BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 4130633 · Received September 30, 2014

    Report

    Report Number
    2520274-2014-13859
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 29, 2014
    Report Date
    September 4, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR NAIL, PART AND LOT NUMBER UNKNOWN. ADDITIONAL COMMON DEVICE NAME: HWC. (B)(6). PMA/510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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 INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE DEVICE HISTORY REVEALED NO ABNORMALITIES WHICH COULD INDICATE PROBLEMS WITH THE LOT OR WITH UNITS OF THE LOT. IN THE CONTEXT OF THE INVESTIGATION THE PRODUCT COMPOSED OF THREE PARTS, WAS DISASSEMBLED AND REASSEMBLED ACCORDING TO THE ASSEMBLING PROCEDURE SE_192010 (INCLUDING A FUNCTIONAL TEST). THE PRODUCT COULD BE REASSEMBLED WITHOUT PROBLEMS. TAKEN TOGETHER THE PRODUCT FULFILLS THE REQUIREMENTS, THEREFORE THE COMPLAINT IS CLASSIFIED AS UNCONFIRMED AND INVALID , BECAUSE NO MALFUNCTION COULD BE DETECTED. 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 A PROXIMAL FEMORAL NAIL ANTIROTATION BLADE (PFNA ) JAMMED, DID NOT TURNED AROUND DURING THE INSERTION, RESULTING IN THE IMPACTOR DEVICE BREAKING. THIS REPORT IS FOR THE UNKNOWN NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609241 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1