Catalog Number 04.004.455 |
Device Problems
Sticking (1597); Separation Failure (2547)
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Patient Problem
Sedation (2368)
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Event Date 10/12/2015 |
Event Type
Injury
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Manufacturer Narrative
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Device was not implanted or explanted during the surgical procedure.An alternate nail was used.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: january 31, 2013.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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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a connection screw could not be separated from an insertion handle during a surgical procedure on (b)(6) 2015.Per the reporter, several attempts were made with all of the appropriate instruments, but the devices could not be separated from one another.It was necessary for the surgeon to remove the nail and replace it with another.The procedure was prolonged by sixty (60) minutes or more.This report is 3 of 3 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device.The subject device was returned along with the complained insertion handle and connecting screw.The subject nail was received with a part of the positioning groove in the top part of the nail expanded.This damage could occur during implant or removal of the nail due to lateral movements.The threads of the nail show some wear marks.A functional test of the received articles showed that the devices could be mounted together without any problems.The complaint issue could not be replicated.Unfortunately without more information or x-rays we are not able to determine the root cause which has led to this complaint.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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