F the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: ,319.006, lot: ft00388.Supplier: (b)(4), release to warehouse date: mar 02, 2017.No non conformance reports were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no relevant non-conformance noted.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection observed broken needle on the returned depth gauge.The broken needle portion was not returned at customer quality.However, all other portions of depth gauge i.E.; protection sleeve, body and slider were returned.No other issues were identified on the remaining portions of the device except for the signs of wear that doesn't affect product functionality.The device condition agree with the complaint description and the complaint was confirmed.Relevant drawings for the returned device were reviewed, and no design issues were noted.Dimensional inspection was not possible as the relevant broken portion was not returned.While no definitive root cause could be determined, it is possible that any unintended excessive forces such as device being dropped during usage/handling could have contributed to complaint condition.The overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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It was reported that on (b)(6) 2018, while inspecting the instruments before putting the sets back together, it was found that the tip of the depth gauge was broken and missing.It is unknown how the device issue occurred.There was no patient involvement as reported.This report is for one (1) depth gauge.This is report 1 of 1 for (b)(4).
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