BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3042851 · Received April 9, 2013

    Report

    Report Number
    8030965-2013-01405
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE REPORTERS COMPLAINT THAT THE BATTERY CASING FELL OFF WAS CONFIRMED. THE UNIT WAS TESTED AND WAS FOUND TO BE DEFECTIVE. THE BATTERY RETENTION MECHANISM IS WORN. THIS IS DUE TO NORMAL WEAR OVER TIME. UPON FURTHER RECEIPT OF ADDITIONAL INFORMATION ABOUT A DELAY IN SURGERY THIS COMPLAINT IS DETERMINED TO BE REPORTABLE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO: DOES NOT MEET THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE MDR REPORT ABILITY STATUS UPDATED TO: DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT: #8030965-2013-01405.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2012, THE BATTERY CASING FELL OFF THE SMALL BATTERY DRIVE. THERE WERE NO DELAYS IN THE PROCEDURE THAT WAS REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT IS FOR A SMALL BATTERY DRIVE. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FACILITY LATER ON REPORTS NO HARM TO PATIENT. PROCEDURE WAS DELAYED LESS THAN 20 MINUTES WHILE A NEW BATTERY DRIVE SET WAS OPENED. NEW SET WAS USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145479 SMALL BATTERY DRIVE HWE SYNTHES GMBH 001102

    Patients

    Seq Age Sex Outcome Treatment
    1