Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown elite bone staple/unknown lot.Part and lot number are unknown; udi number is unknown.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.Used to capture required surgical intervention and modified surgical procedure.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 on an unknown date, the patient underwent an open reduction internal fixation (orif) pubic symphysis diastasis repair si joint for a provisional fixation pubic symphysis diastasis.The patient was implanted with a bme staple 20 mm, 2 legs.The staple was removed and reinserted due to difficulty with insertion.A 6 hole symphysis plate was applied and one si screw placed.There was no further complication intraoperatively or postoperatively.The fracture healed within 3 months.This report is for a an unknown elite bone staple.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.H10 additional narrative: b5: updated event description; e1: updated reporter information; 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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Updated event description: it was reported that on an unknown date, the patient underwent an orif pubic symphysis diastasis, repair si joint for a provisional fixation pubic symphysis diastasis.The patient was implanted with a bme staple 20 mm, 2 legs.The staple was removed and reinserted, difficulty insertion.6 hole symphysis plate applied and one si screw placed.There was no further complication intraoperatively and postoperatively.The fracture healed within 3 months.Procedure and patient outcome were unknown.This complaint involves one (1) device.
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Search Alerts/Recalls
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