BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW ATTACHMENT FOR PEN DRIVE

    MDR report key: 3640087 · Received February 21, 2014

    Report

    Report Number
    8030965-2014-00352
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 23, 2014
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: DZI, ERL AND HBE. THE EUROPEAN LOT NO. IS 1448451-I; THE US LOT # IS 5210313. THE DEVICE IS AN INSTRUMENT AND NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE REPORTER'S COMPLAINT THAT THE (1448451-I) RECIPROCATING SAW ATTACHMENT IS RUNNING HOT COULD NOT BE CONFIRMED. THE UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. DEVICE WAS RECEIVED ON 8/6/2014.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: NOT PREVIOUSLY REPORTED. UPDATED FOR CLARIFICATION TO THE INITIAL MEDWATCH MFR REPORT # 8030965-2014-00352. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014 BY THE SYNTHES (B)(6) CONSULTANT THAT A ELECTRIC PEN DRIVE (PART 05.001.010, LOT 4471) AND RECIPROCATING SAW ATTACHMENT (PART 05.001.040, LOT 5210313) GET HOT WHEN IN USE. NO ADDITIONAL INFORMATION WAS PROVIDED. CONSULTANT CLARIFIED/PROVIDED ADDITIONAL NEW INFORMATION ON AN EMAIL DATED (B)(6) 2014 THAT THE INCIDENT OCCURRED DURING A LEFORT 3 OSTEOTOMY PROCEDURE ON (B)(6) 2014, IT WAS NOTICED THAT, ALTHOUGH THE DEVICE DID FUNCTION DURING THE PROCEDURE, THE RECIPROCATING SAW ATTACHMENT WAS EXTREMELY HOT. PROCEDURE WAS NOT DELAYED, PATIENT WAS NOT HARMED. NO PATIENT DETAILS WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT EVENT IS FOR ONE DEVICE INSTRUMENT, A RECIPROCATING SAW ATTACHMENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109358 RECIPROCATING SAW ATTACHMENT FOR PEN DRIVE HWE SYNTHES GMBH 1448451-I/5210313

    Patients

    Seq Age Sex Outcome Treatment
    1