Catalog Number 314.453 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Sedation (2368)
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Event Date 08/19/2015 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: patient id and weight are unknown.Patient age is unknown; patient is described as (b)(6).Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4).Manufacturing date: 02october2014.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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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: variable angle-distal humerus plate (va-dhp) of medial and dorsolateral were used for an octogenarian female.Plate bending was applied to fix plate in the right position.The surgeon had difficulty to attach the drill sleeve, and found some string-shaped metal debris had come from the reported va-locking screw on the inserting.Therefore, he removed the reported screw.The surgeon inserted another screw instead.The surgeon tightened the screw to some extent because no click sound could be heard.The surgery was extended for thirty (30) minutes.No harm to the patient.This is report 4 of 6 for (b)(4).
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Manufacturer Narrative
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Subject device has been received and is currently in the evaluation process.Investigation is ongoing; 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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A product investigation was completed: 314.453: the first 2-3 mm of the torx shows wear and tear signs.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the provided clinical information it is impossible to determine the exact cause of this occurrence.It is likely that the screw was not been positioned accordingly so that the thread at the screw shaft got damaged during the insertion.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy.Due to the wear and tear signs we conclude that the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected.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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