An event regarding a missing dome hole plug from trident shell device packaging was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: not performed, this is a packaging issue and no adverse consequences to the patient were reported.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been four other events for the lot referenced.The reported trident shell was implanted successfully and there were no adverse affects to the patient.The sales rep has reported that additional bone plug implants were immediately available to complete the surgery.The returned packaging was not returned, hence it could not be confirmed if the dome hole plug was missing from the packaging.One unit from the same lot (lot: 49073501) was found to be available in (b)(4).The device packaging was opened in (b)(4) and it was confirmed that no dome hole plug was present within the packaging.Corrective action/preventive action: (b)(6) has been opened to address missing dome hole plugs from trident shell packaging.Device not returned.
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