Model Number 352.090 |
Device Problems
Entrapment of Device (1212); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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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 on (b)(6) 2019, a medullary reamer head was disengaged from the reamer shaft during a total hip procedure.The surgeon did not place the flexible reamer shaft with reamer head over a reaming rod and the reamer head that was used disengaged from the flexible reamer shaft and was lodged in the femoral canal.They were unable to retrieve the reamer head.Procedure was successfully completed, total hip procedure performed as planned.It was relayed that the patient is recovering fine from the total hip procedure and not given amount of time delayed.There was an attempt to retrieve the reamer head, but that specific information was not supplied, nor was other intervention information.The reason for the total hip procedure was not supplied to sales consultant but mostly performed for osteoarthritis.Sc confirmed this was not a fracture related procedure.Concomitant device reported: unknown flexible reamer shaft (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 9.0mm medullary reamer head.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.No concomitant devices.Previous reported concomitant device became an impacted product.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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Update: no concomitant devices.Previous reported concomitant device became an impacted product.
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Search Alerts/Recalls
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