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Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: patient information not available for reporting.This report is for an unknown locking bolt.Part and lot numbers are unknown; udi number is unknown.Device remains implanted and was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(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 europe reports an event in (b)(6) as follows: it is reported during a procedure to implant a (b)(4) proximal femoral nail antirotation on (b)(6) 2017; surgeon also implanted a 42mm locking bolt.Measurements taken for the necessary bolt length showed 42 mm.Patient physiques is reported as ¿somewhat big¿, surgeon expressed a desire to use a 44mm bolt, which was not available.Surgeon expressed concern for the strength of fixation due to the smaller bolt being used.Surgery was delayed approximately 2 minutes due to this issue.Concomitant devices reported: pfna (part number unknown, lot number unknown, quantity 1).This report is for one (1) locking bolt.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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