It was reported that during an unspecified surgical procedure, it was observed that the kincise pinnacle shell device broke at the t-junction and fell to the floor with the gription shell attached.There were no delays in the surgical procedure as an identical spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.E1: the name and facility are the customer's, the address and contact information are for the company representative.D4: the serial number was unknown.H4: the date of manufacture was unknown.D11: concomitant device: gription shell, therapy date: 8/30/2023.Udi: (b)(4).
|