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: b3: event occurred on an unknown date in november, 2023.H3, h4, h6: 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 cranial-scr plusdrive ø1.6 self-drill l4 had the edges of the threads were found worn and upward, the distal tip was observed partially broken and still remaining attach to the shaft.The device was received with white organic particles attached along the threads.Additionally, it presents nicks and wear on the drive likely from use/engagements of the screwdriver tip, this condition cannot be traced to a manufacturing issue.A dimensional inspection for the cranial-scr plusdrive ø1.6 self-drill l4 was unable to be performed due to post manufacturing damage.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 cranial-scr plusdrive ø1.6 self-drill l4 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 (dhr): a manufacturing record evaluation was performed for the finished device.Product code : 400.834.04s.Lot number# 6720p68.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 04/07/2023.Manufacturing site: jabil bettlach.Expiry date: 01/06/2033.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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Dvice report from synthes reports an event in china as follows: it was reported that on an unknown date in(b)(6) 2023, when the surgeon inserted the screw, the screw head was cracking.The surgeon changed to another screw, and that screw was broken.All pieces were removed from the patient, and another device was used to complete the surgery.There were no adverse consequences to the patient and there was no surgical delay.Upon inspection of the returned product on (b)(6) 2023, it was determined that a second screw was broken.This report involves one cranial-scr plusdrive ø1.6 self-drill l4.This is report 2 of 2 for (b)(4).
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