It was reported by the surgeon that the device needs re-calibrated and checked for not taking the depth of graft that it is being set at; occurred at a hospital, during surgery, or had direct patient impact.The surgery was completed with another device.No further information was available.No adverse events were reported as a result of this malfunction.
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This event has been recorded by zimmer biomet under (b)(4).Product review of the electric dermatome serial number (b)(6) by a zimmer biomet certified service repair technician on 07 may 2020 revealed that the unit met all test and calibration requirements however, the seal, bearings and width plates needed to be replaced.Repair of the device was performed by a zimmer biomet certified service repair technician on 07 may 2020 which included replacement of the seal, bearings, and width plates.The device, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.
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