WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 18MM; SCREW, FIXATION, BONE
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Model Number 02.210.118 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.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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It was reported that upon receiving delivery on an unknown date, two (2) drill bit with depth mark quick coupling and six (6) variable angle locking screw with stardrive recess package arrived empty.There was no patient involvement.This report is for a 2.4mm va locking screw stardrive 18mm.This is report 1 of 1 for (b)(4).Additional reports are captured under (b)(4).
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Event Description
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It was reported that upon receiving delivery on an unknown date, two (2) drill bit with depth mark quick coupling and nine (9) variable angle locking screw with stardrive recess package arrived empty.There was no patient involvement.This report is for a 2.4mm va locking screw stardrive 18mm.This is report 1 of 1 for (b)(4).Additional reports are captured under (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.Corrected event description.The incorrect date was inadvertently utilized in initial medwatch.The correct date is april 25, 2019. 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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