(b)(4) initial report.Report source, foreign - event occurred in (b)(6).We have been informed by the customer that the product will not be returned to zimmer biomet for investigation.Associated product: medical product: g7 dual mobility liner 38mm c, catalog #: 110024461, lot #:638880.Once the investigation has been completed, a supplemental mdr will be submitted.
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(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 4 complaints reported with the item (b)(4) (including initiating complaint).The image of the fractured inserter ring captured in the photograph supplied by the customer ((b)(4) photos) shows clear signs of surface damage on the top face of the ring which can be attributed to expected wear and tear over time, but no definitive information has been provided that could identify the root cause.As the lot number has not been supplied by the customer it was not possible to calculate the time spent in the field.The control of the kit components are covered on the visual inspection instructions in (b)(4) reusable instrument lifespan manual: inspection/function testing while loading instruments into their respective instrument cases after cleaning and prior to sterilization, reference the manual and follow the instructions below.1.Instruments should be inspected for completeness and function.2.Inspection includes inspecting for all forms of wear outlined in this manual.3.Results of assembly, actuation, and extent of all forms of wear should be considered in determining whether an instrument is suitable for use.4.If the reusable instrument is determined no longer suitable for use or if the suitability for use is still in question after inspecting the instrument and referencing the reusable instrument lifespan manual, initiate the process to return the instrument(s) to the manufacturer.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information, if any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product not returned.
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