The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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It was reported that on (b)(6) 2020 the two (2) bending template holes for reconstruction plates, one (1) bending template for matrixrib locking plates, one (1) screwdriver blade hexagonal self retain plusdrive and two (2) titanium locking plate holes adaption were found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This report is for one bending template for matrixrib locking plates.This is report 2 of 5 for (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 03.501.072.Lot: 3055481.Manufacturing site: hägendorf.Release to warehouse date: 20 jan 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: visual inspection performed at customer quality (cq) identified that bending template broke at the juncture between the 8- & 9-hole section.The break is jagged and oblique.In addition the template is bent indicating it has been in use during its lifetime.A device failure was identified.Measured dimensions: conforming.Document specification.The following documents were reviewed as part of this investigation: rib plate bending template.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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