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Catalog Number 03.037.024 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, the spiral blade was jammed, and no longer detached.The surgery was completed successfully with 30 minutes delay.There was no patient consequence.This complaint involves two (2) devices.This report is for (1) helical blade inserter.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A product investigation was conducted.Visual inspection: the received tfna helical-blade impact is in an almost brand-new good condition.Functional test: a functional test was performed with the returned damaged connecscr f/tfna helic blade+scr and has shown that it is not possible to assemble adequately the tfna helical-blade impact in question as the thread of connecscrew is damaged.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the complaint is rated as unconfirmed for this tfna helical-blade impact because that there is no allegation against of this device.A functional test was performed with the returned damaged connecscr f/tfna helic blade+scr and has shown that it is not possible to assemble adequately the tfna helical-blade impact in question as the thread of connecscrew is damaged.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.A device history record (dhr) review was conducted: part number: 03.037.024.Lot number: t173029.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2019.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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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