WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM; GAUGE, DEPTH
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Model Number SD319.002 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6)2022, the depth gauge tips broke off during processing.No revision surgery or hardware removal required.No medical intervention was required.There was no patient consequence.This report is for a depth gauge for 2.0mm and 2.4mm screws-70mm.This is report 2 of 2 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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: initial reporter is a synthes employee.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.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.H10 additional narrative: h3, h6: a manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the depth gauge needle tip of depth gauge for 2.0/2.4mm screws-70mm has broken, the broken fragments is visible in photos.No other problems was reported.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for depth gauge for 2.0/2.4mm screws-70mm.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.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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