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Device report from synthes reports an event in the usa as follows: product code: 319.
006, product name: depth gauge for 2.
0mm and 2.
4mm screws, lot number: ft00443.
It was reported that physical finding of the device is broken.
This report is for one (1) depth gauge f/scr ø2+2.
4 meas-range up-t.
This is report 1 of 1 for complaint (b)(4).
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Product complaint # (b)(4).
Initial reporter is a j&j employee.
Device history lot: part # 319.
006, synthes lot # ft00443, supplier lot # ft00443, release to warehouse date: 15 may2017, supplier: (b)(4).
No ncrs were generated during production.
Note: ri information was retrieved from (b)(4), as it is the same lot number and lot number name device history 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.
Investigation summary: product code: 319.
006, product name: depth gauge for 2.
0mm and 2.
4mm screws, lot number: ft00443.
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 depth gauge f/scr ø2+2.
4 meas-range up-t had the needle broken, fragment is not included in the package.
A dimensional inspection for the depth gauge f/scr ø2+2.
4 meas-range up-t and was unable to be performed 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 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 depth gauge f/scr ø2+2.
4 meas-range up-t 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 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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