WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY
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Model Number 04.037.165S |
Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Discomfort (2330); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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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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It was reported that on an unknown date, the patient was scheduled to undergo a replacement of 105mm helical blade but they noticed that the trochanteric fixation nail-advanced (tfna) was broken at the nail junction blade interface.Both the nail and helical blade were removed and replaced.There was no patient consequence reported.Surgical procedure delay and patient outcome is unknown.Concomitant devices reported: distal locking screw (part/lot unknown, quantity unknown); tfna blade (part 04.038.305s, lot unknown, quantity 1) this report is for a tfna nail.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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(b)(4).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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It was reported that on (b)(6) 2018, the patient was scheduled to undergo a replacement of 105mm helical blade due to discomfort in the patient.When the blade was removed, it was noticed the trochanteric fixation nail-advanced (tfna) was broken at the nail junction blade interface.Both the nail and helical blade were removed and replaced.There was no patient consequence reported.Surgical outcome is unknown.Concomitant devices: distal locking screw (part: unknown, lot: unknown, quantity: unknown), tfna blade (part: 04.038.305s, lot: unknown, quantity: 1).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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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