Device report from (b)(6) reports an event as follows: it was reported that an order of patient-critical parts was delayed by twenty-four (24) hours due to missing paperwork.Concomitant devices: cancellousscr synapse ø3.5 (part: 04.614.016, lot: unknown, quantity: 2); cancellousscr synapse ø3.5 (part: 04.614.018, lot: unknown, quantity: 3); cancellousscr synapse ø3.5 (part: 04.614.024, lot: unknown, quantity: 4); cancellousscr synapse ø3.5 (part: 04.614.026, lot: unknown, quantity: 3); cancellousscr synapse ø3.5 (part: 04.614.028, lot: unknown, quantity: 8); cancellousscr synapse ø3.5 (part: 04.614.030, lot: unknown, quantity: 1); cancellousscr synapse ø3.5 (part: 04.614.032, lot: unknown, quantity: 4); shaft-scr synapse ø3.5 l26 tan (part: 04.614.326, lot: unknown, quantity: 2); shaft-scr synapse ø3.5 l28 tan (part: 04.614.328, lot: unknown, quantity: 2); shaft-scr synapse ø3.5 l30 tan (part: 04.614.330, lot: unknown, quantity: 8); shaft-scr synapse ø3.5 l32 tan (part: 04.614.332, lot: unknown, quantity: 10); shaft-scr synapse ø3.5 l34 tan (part: 04.614.334, lot: unknown, quantity: 2); cancellousscr synapse ø4.5 (part: 04.614.224, lot: unknown, quantity: 4); cancellousscr synapse ø4.5 (part: 04.614.226, lot: unknown, quantity: 4); cancellousscr synapse ø4.5 (part: 04.614.228, lot: unknown, quantity: 2); cancellousscr synapse ø4.5 (part: 04.614.230, lot: unknown, quantity: 4); cancellousscr synapse ø4.5 (part: 04.614.236, lot: unknown, quantity: 4); lockscr synapse tan (part: 04.614.508, lot: unknown, quantity: 20); rod ø3.5 l240 ti gold (part: 498.957, lot: unknown, quantity: 3); mono/polyaxial screw (part: unknown, lot: unknown, quantity: 1); locking/set screw (part: unknown, lot: unknown, quantity: 1).This report is for an unknown mono/polyaxial screws.This is report 2 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.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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