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Catalog Number 391.962 |
Device Problems
Break (1069); Material Fragmentation (1261)
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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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Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: oct 7, 2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on oct 6, 2014.No non-conformances were generated during the production of the subject device.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 the back table while preparing for an unknown procedure on unknown date, a piece of the plate bending/cutting pliers broke off.A similar device was available to the complete the procedure without any delay.The patient status after the surgery is unknown.There was no patient harm reported.This report is 1 of 1 for com-(b)(4).
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Manufacturer Narrative
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The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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Manufacturer Narrative
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Additional narrative: a product investigation was completed: a visual inspection, device history record review, and drawing review were performed as part of this investigation.This complaint is confirmed.Per the technique guide, the 391.962 bending/cutting pliers are an instrument routinely used in the 2.7mm variable angle locking calcaneal plating system.The device was returned and reported to have had a piece broken off.This condition is confirmed; one of the carbide inserts used for cutting is entirely missing from the device and was not returned.It is likely that over two years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 10/2014 and is over two years old.The balance of the returned device is in fairly worn condition and does not easily open or close.The relevant 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.Upon review of the device history record, no non-conformance reports germane to the complaint condition were generated during the production of this device.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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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Search Alerts/Recalls
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