Event occurred on an unknown date in 2020.Additional procode: hto.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 the patient underwent surgery using the ria 2 on the right proximal femur to have bone and bone marrow harvested.The procedure was successfully completed.On (b)(6) 2020 the patient was hospitalized again with a right femur fracture at the grafting site.The right femur was treated with femoral nail and cerclage from another company on (b)(6)2020.There was patient consequence.There is no further information available.Concomitant devices reported: unknown nail (part# unknown, lot# unknown, quantity 1).Unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) 16.0mm reamer head for ria 2 sterile.This is report 1 of 3 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the fracture of the femur can be confirmed on the received x-rays.If this occurrence is in any relation to the ria 2 reamer system cannot be confirmed based on these post-operative pictures (female_1958.Pdf), therefore the complaint is rated as n/a in the confirmed field.Product was not returned therefore no further investigation possible.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available (information or/and material), the investigation will be updated as applicable.Device history lot : part number:03.404.028s, synthes lot number: 62p2880, supplier lot number: n/a, release to warehouse date: 30jun2020, expiration date: 01jul2030, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.
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