Catalog Number 03.812.508 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problems
Sedation (2368); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/15/2014 |
Event Type
Injury
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Manufacturer Narrative
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Initially reported as (b)(6) 2014; however, should have been reported as (b)(6) 2014.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 europe reports an event in (b)(6) as follows: it was reported the tip of the sleeve broke off in the handle and was stuck during surgery.The broken piece was able to be removed after the surgery was completed.The surgery was prolonged one hour.It was reported there was no serious injury to the patient due to this event.This is report 1 of 5 for com-(b)(4).
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Manufacturer Narrative
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Device is an instrument and is not implanted/explanted.(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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Search Alerts/Recalls
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