SYNTHES BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION,APPARATUS,NON-POWERED
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Catalog Number 357.371 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Patient information is not available for reporting.Date device found worn in surgery is not known.Udi: (b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Concomitant device therapy date is not known.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 is reported the surgeon noted a buttress compression nut for a guide sleeve for trochanteric fixation nails is worn and will not hold during surgery.No further information was provided.Concomitant devices reported: guide sleeve (part 357.369, lot unknown, quantity 1).This report is for one (1) buttress/compression nut.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device history records review was completed for part# 357.371, lot# 4436456.Supplier: (b)(4), release to warehouse date: nov 01, 2002.Review of the device history records(s) showed that there are no potential issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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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An additional instrument was available in the operating room to complete the surgery.No delay in surgery.Surgery was completed successfully.Patient is reported in stable condition.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.The 357.371 lot number 4436456 buttress/compression nut was returned and reported to have become worn out and no longer hold.This complaint condition was likely caused by over fourteen years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection and drawing review were performed as part of this investigation.This complaint is confirmed.No new malfunctions were observed during the course of this investigation.The 357.371 buttress/compression nut is an instrument routinely used in the titanium trochanteric fixation nail system (technique guide).The device was returned and reported to have become worn out and no longer hold.This condition is confirmed; the outer edge of the lip which connects to the aiming arm shows significant wear and deformation.In addition to significant wear on the mating aiming arm, this likely led the device not holding together.The device was manufactured in 11/2002 and is over fourteen years old.The balance of the returned device is in otherwise fair condition with some superficial wear along the outer knurled edge.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.All measurements have been performed by calipers.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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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