Catalog Number 352.040 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/23/2024 |
Event Type
malfunction
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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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10 therapy date: (b)(6), 2024.E1 initial report phone number: (b)(6).H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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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Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2024, during the procedure the synream shaft broke and the drill head remained in the medullary canal.The patient has histologically confirmed breast cancer with multiple osseous metastases.The right femur was markedly osteolytic with a considerable risk of fracture.On the opposite side on the left multiple metastases with risk of fracture.However, the bone substance was still sufficient here, so there was indication for nailless osteosynthesis.Entry into the operating room, lateral position, surgical disinfection and sterile disinfection of the operating field.Started with the left side for nail implantation.Presentation was under visualization control.Opening of the medullary canal, insertion of an intramedullary wire was performed.Control in 2 planes.Then reaming of the medullary canal was conducted.During reaming at 12 mm, the synream shaft broke off and the drill head remained in the medullary canal.Accordingly, the medullary canal needed to be opened through the knee and the reamer retrieved, as it could no longer be pulled out using the wire.The surgical team had to drill over the reamer, then knock it out with the nail inserted antegrade and then recovered the distal drill head.They then placed the nail in its final position and inserted the femoral lag screw in the center/center position.To do this, the femoral neck wire needed to be placed first.They drilled over of the femoral neck wire and inserted the nail.Static locking proximally was performed.They then drilled the distal locking under bv.Inserted the corresponding screw under bv, then irrigation of the situs both proximally and distally was performed.Layered proximal as well as distal.Layered wound closure of all access points.Sterile dressing was conducted.The surgery and anesthesia time was prolonged by the incident, and an additional surgical access was required.This report involves one (1) 5.0mm flexible shaft.This is report 2 of 2 for (b)(4).
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Search Alerts/Recalls
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