(b)(4).This is a combined initial and final report.Medical product: oxf anat brg rt md size 3 pma, catalog #: 159575, lot #: 157210.Concomitant medical products: medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: 485350.Medical product: oxford resection 3pk hall hub, catalog #: 506078, lot #: 305224.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00333, 3002806535-2020-00335.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints database over the last 3 years has found 1 similar complaint for the item code 159575,15 similar complaints for the item code 161469 and 3 similar complaints for the item code 154721.No trends were identified from complaint history review for the item 159575 and 154721.For item 161469, 2 complaints were reported with same hospital.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to severe pain.Risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to severe pain.Pain is documented as a potential harm as an outcome of a number of hazards assessed by the rmf.Pain is considered a severity of 3: moderate, which as per the severity table listed within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of this complaint (surgical intervention) is considered to be within the severity of the rmr.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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