Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, patient underwent for a surgery.During the surgery, the surgeon unable to turn the insertion device for rod connection.While using the screwdriver, the collet inside the screwhead happened to be turned 90 degrees.The surgery was completed with 30-minutes surgical delay.No further information is available.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).This complaint involves three (3) devices.This report is for (1) exp 6.35 ti uni 7 x 45mm.This report is 1 of 3 for (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that exp 6.35 ti uni 7 x 45mm the collect and hex of the screw were deformed, and no other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.Functional test cannot be performed since the device was returned by itself but the alleged condition can be confirmed since the deformed condition might have impacted the complaint condition.The observed condition of exp 6.35 ti uni 7 x 45mm in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for exp 6.35 ti uni 7 x 45mm.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 179988745.Lot : 237127.Was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: 15.04.2019.Qty: (b)(4).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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