Catalog Number 03.118.007 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j 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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, since the start of the procedure, the percutaneous depth gauge has abnormal tip torque and is very difficult to measure the screws needed.No further information provided.This report is for one (1) percutaneous depth gauge for 2.7mm 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.H3, h4, h6- the complaint device (medidor de profundidad, percutáneo) was not received for investigation.This complaint is not confirmed as a photo inspection does not show malfunction or issues within the device.A manufacturing record evaluation cannot be performed due to lot number being unknown.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional information.During the investigation no product design issues or discrepancies were observed (based on the images) 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 history lot : a manufacturing record evaluation cannot be performed due to lot number being unknown.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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