Catalog Number 02.124.414S |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 reports an event in (b)(6) as follows: it was reported that on an unknown date in 2020, the condylar plate broke four (4) weeks after an unknown surgical procedure.No further information provided.Concomitant device reported: va locking screw stardrive (part # 02.231.285s, lot # 22p9698, quantity 2), va locking screw stardrive (part # 02.231.285s, lot # 38p6487, quantity 1) va locking screw stardrive (part # 02.231.290s, lot #:28p3345, quantity 1),va locking screw stardrive (part # 02.231.280s, lot # 50p0604, quantity 1), va locking screw stardrive (part # 02.231.275s, lot # 44p1338 quantity 1), va locking screw stardrive ( part # 02.231.236s, lot # 33p5728, quantity 3), va periprosthetic lock screw (part # 02.231.016s, lot # l654699, quantity 1), va periprosthetic lock screw (part # 02.231.016s, lot #l752913, quantity 1), va periprosthetic lock screw (part # 02.231.014s, lot # çl81203, quantity 2).This report is for one (1) 4.5mm va-lcp curved condylar plate/14hole/301mm/rt-ster.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: visual inspection: the plate was found broken at the 7th hole, counted from the end side.Furthermore, at the threaded 11th hole is a crack visible.No other visual damage could be observed at the va-lcp condylar plate all in all the plate are in a used condition.Dimensional inspection was performed as below: document/drawing: va-lcp condylar plate.Document/drawing.Feature/test/description: width (near broken area).Specification.Gage 3-01-19789 results "pass".Feature/test/description: thick (near broken area).Specification: gage 3-01-19789 results "pass".The measured dimensions were found to be within the given specifications per the drawings referenced above.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard iso 5832-1 for implants for surgery, stainless steel.The fracture face is homogenous, which indicates material conformity.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the received va-lcp condylar plate does confirm the reported complaint condition, hence the complaint will be rated as confirmed.This lot was manufactured in may 2020, all devices are distributed and we are not aware of any other complaint for this part- and lot number combination.This and the findings above let us exclude a manufacturing related issue.Based on the provided information we are not able to determine the exact cause.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot: part number: 02.124.414s, lot number: 52p5486, manufacturing site: mezzovico, expiry date: may 1, 2030, release to warehouse date: may 27, 2020.A manufacturing record evaluation was performed for the involved device lot number, and no non-conformances were identified.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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