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Catalog Number 04.027.055S |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device used for treatment, not diagnosis.Patient information not available for reporting.Blade may also be: 95mm blade (04.027.054s).Udi: (b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.510k#unknown.Device history records review was conducted.The report indicates that the: manufacturing location: part 04.027.055s / lot 9662682.Manufacturing location: (b)(4).Manufacturing date: 25.Sep.2015 expiry date: 01.Sep.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.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 on an event in (b)(6) as follows: it was reported that the reported device was used in surgery for left femur trochanteric fracture on (b)(6) 2017.After inserting a pfna (proximal femoral nailing antirotation) blade 100mm, the surgeon attempted to lock using inserter, but failed.Thus he extracted and replaced it with 95mm blade.Then he was able to lock this time and completed the surgery.The surgery was extended for 20 minutes.There is no information available about patient outcome.This complaint involves 1 part.Concomitant devices: 1x unk nail, 1x unk inserter.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device returned to manufacturer.Initial reporter hospital phone number: (b)(6).A product investigation was performed on the returned subject device pfna-ii blade l100 tan (part # 04.027.055s, lot # 9662682.The device was forwarded to manufacturing plant for investigation.The product was returned in a packaging different from the original packaging.The laser marking was readable.Traces of repeated use were visible at the location on the tops of the flutes.The investigation revealed that there is no dimensional issue or another issue related to manufacturing which could be the case for the difficulties to lock the blade.All dimensions relevant for the function of the product were measured, and fulfill the specifications.The raw material certificates were checked and it was found that all used raw material fulfilled the specifications.Complained issue (the surgeon attempted to lock using inserter, but failed) could not be replicated and/or confirmed based on the provided investigation.Based on this the complaint is rated as not confirmed and not valid from the point of view of the manufacturing site.Exact root cause for the complained issue (the surgeon attempted to lock using inserter, but failed) could not be found throughout this investigation.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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