Evaluation summary post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted that the handle was detached from the rod.A tack was protruding from the shaft.Functional testing was precluded due to the observed condition of the instrument.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the observed conditions may occur if the instrument is handled roughly during use.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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