Occupation: initial reporter is synthes sales representative.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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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.H10 additional narrative: d8.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.501.080, lot: 8652176, manufacturing site: haegendorf, release to warehouse date: 10.Oct.2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was conducted.Service & repair evaluation: the customer reported the device had found broken and was unable to tighten properly.The repair technician reported the device required further testing at the vendor.Lube/oil/clean is the reason for repair.The cause of the issue is unknown.The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2019 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.H11 corrected data: d10.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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