Catalog Number 357.402 |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing location: (b)(4) - manufacturing date: april 14, 2010.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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 a locking bolt measuring device for trochanteric fixation nails fell apart during reassembly in sterile processing.The little ball inside that marks the compression and allows for gradual sliding of the sleeve was missing.There was no reported patient or surgical involvement.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.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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Manufacturer Narrative
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Additional manufacture date 13march2012.A product investigation was completed: the complaint condition of loose is confirmed on both devices as upon visual inspection; it can be seen that the ball bearing on the internal slider on the complaint device is missing.The distal hooked tip of the devices is undamaged.It is unknown what caused the complaint condition, but it is most likely due to wear over the life of the device.Per the technique guide, the 357.402 locking bolt measuring device is an instrument routinely used in the titanium trochanteric fixation nail system to measure locking bolt/screw length.The relevant drawings were reviewed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.It is most likely this failure mode was due to the method of use or damage during sterile processing while in a disassembled state corrected device history record review: manufacturing location: (b)(4).Manufacturing date: 13march2012.Lot should have 6897935.Part: 357.402, lot: 6897935 (non-sterile) - locking bolt measuring device f/trochanteric fixation nails.Lot was release to the warehouse on 14april2010.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 while re-assembling two locking bolt measuring devices f/trochanteric fixation nails during sterile processing, they fell apart.The little ball inside to mark the compression was missing that makes the sleeve to slide gradually.There was no patient involvement and no procedure.
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Manufacturer Narrative
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(b)(6).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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