Model Number 338.31 |
Device Problems
Break (1069); Entrapment of Device (1212); Material Fragmentation (1261)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter is company representative.Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received.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, the threads from the dynamic hip screw (dhs) connecting screw stripped off into a lag screw.The threads were still in the 100 mm lag screw.The patient had a femoral neck fracture.Fragments were generated.There was no surgical delay reported.Procedure was successfully completed.There were no patient consequences.Concomitant devices reported: dhs®/dcs® one-step lag screw 12.7 mm thread/100 mm (part # 280.301, lot # unknown, quantity# 1).This complaint involves one (1) device this report is for one (1) dhs®/dcs® coupling screw.This is report 1 of 1 for (b)(4).
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Event Description
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It was further reported by the sales consultant that the surgeon stopped using that dhs instrument and opened a back up device and tagged the broken instruments which caused a 3 minute surgical delay.
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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.Concomitant medical products: 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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Search Alerts/Recalls
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