WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE, DEPTH
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Model Number 319.004 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes reports an event in the usa as follows: it was reported that on an unknown date, the tip of depth gauge for 1.3mm and 1.5mm screws was bent.There was no patient or surgeon involvement.There was no patient consequence.This complaint involves one (1) device depth gauge for 1.3mm and 1.5mm screws.This is report 1 of 1 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.H10 additional narrative: investigation summary: 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 needle tip of depth gauge for 1.3mm and 1.5mm screws has bent.Also the surface of dowel pin was found scratched.No other problem was reported.A dimensional inspection was not performed for the depth gauge for 1.3mm and 1.5mm screws due to the design of the device.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 depth gauge for 1.3mm and 1.5mm screws 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.Device history review: review of the device history record(s) for part # 319.004, synthes lot # 4287837 showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.
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