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Catalog Number 459.320 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient information not provided by reporter.Awareness date is an assumption, actual date unknown.Per product description: pfna ø9 125° l240 tan (b)(4).Device is not expected to be returned for manufacturer review/investigation.Not explanted.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an event in (b)(6) as follows: it was reported that when they were doing the distal locking in 240mm nail, the bolt was off the peg, after the surgeons performed a free hand locking, there was a 30 minutes delay to surgery time, no fragments left in patient.No information about patient condition received.This complaint involves two parts.This report is 2 of 2 for (b)(4).
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Search Alerts/Recalls
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