Catalog Number 03.224.001 |
Device Problems
Accessory Incompatible (1004); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/04/2014 |
Event Type
malfunction
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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: the products were used for an intracapsular hip fracture case.It was reported that the connecting screw was inserted into the insertion instrument ((b)(4)), and the insertion instrument was connected to the dynaminc hip screw (dhs) locking blade properly.While the surgeon was turning the screw driver and tighten the blade, the surgeon felt the screw driver was spinning loosely.Then it was found that the connecting screw was broken at the shaft.The surgeon decided to leave the broken piece of the screw in the bone and finished the operation.There was no extension for operative duration and no adverse consequence to the patient.This report is 1 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Device is an instrument and is not implanted/explanted.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.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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An evaluation was performed on the returned device.As received condition of device; the article was investigated but does not show any damage and in working order.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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(b)(4): the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 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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