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Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Hypovolemic Shock (1917)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown tfn nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device was not reported to have been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 patient presented on an unknown date with transtrochanteric fracture and multiple unidentified comorbidities which required rapid surgical intervention.A trochanteric fixation nail advanced (tfna) procedure was scheduled.It is unknown when it was discovered that there were no tfnas available.It was then decided to use the trochanteric fixation nail (tfn) product.During the tfn procedure, surgeon attempted multiple times to insert the helical blade but was not successful.It was then noted the tfn nail¿s locking mechanism was pre-deployed.Surgeon removed the nail and backed out the locking mechanism, then re-inserted the nail and was then able to insert the helical blade.Patient experienced blood loss and was reported to have gone into shock.Surgery was completed with a delay of approximately two and one half (2 ½) hours.Concomitant device reported: tfn helical blade (part number unknown, lot number unknown, quantity 1).
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Search Alerts/Recalls
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