Model Number 286750131N |
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 10/04/2022 |
Event Type
malfunction
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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.Date of event: only the event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: reporter is a j&j employee.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.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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Event Description
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Device report from synthes reports an event in switzerland as follows: it was reported that on an unknown date, imprecision was encountered while navigating screws during a t5-l3 fixation procedure using viper prime screws (mounted with a non-synthes product).Intra-operative navigation system and 3d imaging were non-synthes products.The first navigation phase occurred in the following order: t5-r, t6-r, t7-r, t8-r, t9-r, t5-l, t6-l, t7-l, t8-l, t9-l, t10-l).No apparent navigation abnormalities nor inaccuracies were countered during this navigation phase.No instrument recalibration nor adjustments of any sort on either the screwdriver or the patient¿s reference had been performed during this navigation phase.The second 3d navigation was acquired for control purposes.The positions of the first 5 screws placed on the upper right side of the patient (t5 ¿ t9 right) were found to be all medially shifted.All other screws (t5 ¿ t9 left) were found to be correctly placed.Three out of the 5 misplaced screws had to be removed / replaced (t5 r, t8 r and t9 r).Third 3d navigation acquisition was done for control purposes.All replaced screws (t5 r, t8 r and t9 r) showed to be properly and adequately inserted into each pedicle / vertebra.Fourth 3d navigation acquisition was completed.Patient¿s reference was attached to the spinous process of l3.Re-calibration of the viperprime screwdriver mounted with non-synthes product occurred.After the fifth navigation acquisition, all screws were found the be placed according to the way they had been navigated and according to the surgeon¿s decision.There was a surgical delay of 45 minutes in relation to this event.No further information is available.This report involves one viper prime nav shaft assy.This is report 2 of 2 for (b)(4).
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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.D4, h4.A review of the receiving inspection (ri) for viper prime nav shaft assy was conducted identifying that lot number mf4407503 was released in two batches.Batch1: lot qty of (b)(4) units were released on 29 june 2020 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 11 june 2020 with no discrepancies.Supplier: depuy : metal craft machine & engineering 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 there was no damage or defects observed on the surface of the viper prime nav shaft assy, p/n: 286750131n.A dimensional inspection was performed for the viper prime nav shaft assy, p/n: 286750131n and met specifications.A functional test was not conducted as the rest of the navigation system, including the screws, was not returned for evaluation.The device was assembled to the returned brainlab adaptor, without any observed problems.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the viper prime nav shaft assy, p/n: 286750131n was found to have no damage or defects.No definitive root cause could 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.B3: event date udpated.E1-e4: initial reporter corrected.
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Search Alerts/Recalls
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