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OBERDORF SYNTHES PRODUKTIONS GMBH CONDYL-PL 95 14HO L60 TI; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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| Catalog Number 437.MAB.13980 |
| Device Problem
Break (1069)
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| Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(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, a condylar plate was broken.The patient underwent revision surgery on (b)(6) 2020.No further information reported.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 4.5mm va-lcp curved condylar plate/14 hole/301mm/right.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.G4: date received by manufacturer on the initial report should be june 2, 2020.Investigation summary: investigation site: customer quality (cq) zuchwil, selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the plate is broken apart at the crossover from the flat part to the first bend at the upper part of the first slotted hole.In general is the device is in a used condition with scratches and wear marks all over.Dimensional inspection: checked dimensions with caliper per drawing: plate width specification = pass plate thickness specification = pass slot width specification = pass.Drawing specification review: drawing was reviewed to verify the relevant dimensions of the plate and the material specification.The review of the manufacturing documents has shown that the correct material for unalloyed titanium implants for surgery.Investigation conclusion: the complaint is confirmed as the plate is broken as complained.During the performed evaluation no manufacturing related issue could be detected.This lot was manufactured in september 2002 and we are not aware of any other complaint for this article- and lot combination.Based on the provided information the exact cause of this occurrence cannot be defined.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.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 437.Mab.13980, lot: 2043463, manufacturing site: bettlach, supplier: (b)(4), release to warehouse date: september 18, 2002.A manufacturing record evaluation was performed for the finished 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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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.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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Concomitant devices reported: cortex screw (part#: 414.832, lot#: 1l37459, quantity: 1), cortex screw (part#: 414.832, lot#: 6l00456, quantity: 1), cortex screw (part#: 414.834, lot#: 2l39036, quantity: 1), cortex screw (part#: 414.836, lot#: 5l46201, quantity: 1), cortex screw (part#: 414.838, lot#: l780760, quantity: 1), cortex screw (part#: 414.856, lot#: l407034, quantity: 1), cortex screw (part#: 414.880, lot#: l776304, quantity: 1), cancellous bone screw (part#: 418.050, lot#: 9231986, quantity: 1), cancellous bone screw (part#: 418.075, lot#: l358321, quantity: 1).
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