Part # 319.006, synthes lot # h663677, supplier lot # h663677, release to warehouse date: 07 mar 2019, supplier: avalign technologies-nemcomed, no ncr's were generated during production.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.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (p/n: 319.006, lot #: h663677) was received with the needle component broken from the slider.The transverse fracture of the needle is located at the interface between the needle and slider.The distal portion of the needle was observed to be bent off-axis.The protection sleeve component is missing.No other issues were identified.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: needle diameter = conforming.Document/specification review: -depth gauge for 2.0/ 2.4mm screws.-protection sleeve.-needle.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the needle component was broken from the slider.The transverse fracture of the needle is located at the interface between the needle and slider.The distal portion of the needle was observed to be bent off-axis and missing protection sleeve.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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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