DEPUY SPINE INC. VIPER PRIME PALM HANDLE; SURGICAL INSTRUMENT HANDLE, NON-TORQUE-LIMITING
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Model Number 286750036 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2022 |
Event Type
malfunction
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Event Description
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Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 3 for (b)(4).It was reported by the customer in canada that during a posterior spinal fusion procedure on (b)(6) 2022, it was observed that it was difficult to screw the gauge inside the handle while setting up for the stylet inside the gauge which then goes into the handle.According to the report, the silver lining of the handles were damaged, causing difficulty to screw the gauge of the stylet inside.There was no delay as we found this out during the setup.There were no adverse patient consequences reported.No additional information was provided.This report is for one (1) viper prime palm handle device.This complaint involves three (3) devices.
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Manufacturer Narrative
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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.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
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Manufacturer Narrative
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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.H6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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Manufacturer Narrative
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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.H10 additional narrative: h3, h6: a review of the receiving inspection (ri) for viper prime palm handle was conducted identifying that lot number mf4293003 was released in one batch.Batch1: released on 11 april 2018 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 viper prime palm handle had normal cosmetic details as wear and scratches around the surface that could be caused for repetitive use or unintended forces applied.Also, the handle core component (p/n: 103142011) had impaction marks.No other issues were observed.A functional test was performed using a pin gage ø 10.90 mm to evaluate the assemble condition reported.After few attempts, it was not possible place the the pin into the handle core component therefore, the allegation can be confirmed.A dimensional inspection was not performed for the viper prime palm handle 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 viper prime palm handle 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.Drawing/specifications reviewed.Viper primer palm handle (current/manufactured).Viper prime palm handle component (current/manufactured).Viper prime handle core (current/manufactured).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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