WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM PLATES; INSTRUMENT, CUTTING, ORTHOPEDIC
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Model Number 391.98 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that during routine inspection, the plate cutter and tip for plate holder both were found to be broken.There was no patient involvement.This report is for one (1) plate cutter for 1.0mm, 1.3mm, 1.5mm, 2.0mm plates.This is report 1 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Initial reporter occupation: reporter is a j&j sales representative.Photo investigation: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that one of the plate cutter of the pl cutter for 1.0, 1.3, 1.5, 2.0 pls was found broken, the broken fragment is visible in photos.No others problems were found.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for pl cutter for 1.0, 1.3, 1.5, 2.0 pls.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the cutter of the pl cutter for 1.0, 1.3, 1.5, 2.0 pls has broken, the broken fragment was returned.No other issues were observed.A dimensional inspection was not performed for the pl cutter for 1.0, 1.3, 1.5, 2.0 pls due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the pl cutter for 1.0, 1.3, 1.5, 2.0 pls would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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