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Catalog Number 472.102S |
Device Problem
Failure to Align (2522)
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Patient Problem
Sedation (2368)
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Event Date 12/29/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).Device malfunctioned inter-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: it was reported that a surgery to apply proximal femoral nail antirotation (pfna) for proximal femur was held on (b)(6) 2015.During the surgery, a pfna blade interfered with a pfna nail during the insertion.The surgeon attempted to place 3.2mm guide wire, and moved the insertion handle back and forth to insert the pfna blade into the pfna nail.The attempt was unsuccessful, and the tip of the blade was chipped by the attempt.The surgeon utilized a new pfna blade and pfna nail.The two devices again interfered and the surgeon needed to use a new, third pfna blade and pfna nail.The third attempt was successful and the surgeon was able to insert the blade into the nail.There was a surgical delay of 60 minutes reported.This is report 2 of 7 for (b)(4).
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Manufacturer Narrative
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(b)(4): subject device has been received and is currently in the evaluation process.Dhr review - manufacturing location: (b)(4).Manufacturing date: 26 may 2015.Expiry date: 1 may 2025.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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Manufacturer Narrative
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A manufacturing evaluation was completed: the product was returned in a packaging different from the original packaging.The laser marking was readable.A device history record (dhr) review was performed for the affected lots, no abnormalities or deviations were detected, which could lead to the complaint failure.All dimensions relevant in the interaction between the returned blades and nails were measured, and fulfill the specifications.Based on this the complaint is rated as not confirmed and not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and/or confirmed.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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