Catalog Number 292.650 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 07/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during a knee arthroplasty surgery a wire broke and the broken wire remained in the body of the patient.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Complainant part is no longer expected to be returned for manufacturer review/investigation.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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The procedure was for a femur neck fracture.It was reported the procedure was completed successfully with no additional medical intervention needed.It was noted there is no planned procedure to go in and remove the fragment.
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Search Alerts/Recalls
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