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Catalog Number 292.620S |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(6).Without a lot number the device history records review could not be completed.Product was not returned.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported during an unknown procedure on (b)(6) 2020, the guide wire broke intraoperatively into a screw and patient's bone.The fragments inside the bone were not removed.The patient was currently still hospitalized due to the risk of infection at the time of this report.No known surgical delay.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity # 1).This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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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Event Description
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There was a surgical delay of ten (10) minutes.Concomitant devices: screw (part: unknown, lot: unknown, quantity: 1), reamer (part# unknown, lot: unknown, quantity: 1).
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Search Alerts/Recalls
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