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Device Problem
Material Deformation (2976)
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Patient Problem
No Code Available (3191)
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Event Date 11/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for an unknown locking screw.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review / investigation.(b)(4).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 that on (b)(6) 2019, during an unknown procedure, the tip of the screwdriver did not engage with screw head properly; it strips the screws.A replacement screwdriver with the same set of screws was used to complete the procedure successfully.Surgery was delayed by two (2) minutes.No fragments were generated.No reported consequences to the patient.This complaint involves two (2) devices.This report is for one (1) unknown locking screw.This is report 2 of 2 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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Search Alerts/Recalls
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