Model Number 286750032 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 11/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that during a transforaminal lumbar (tlif) procedure on (b)(6) 2019, the scrub nurse had had difficulty loading the implant.The surgeon was about to implant but noticed the cage was not straight; the interface with inserter was not straight and in alignment with inserter.Another concorde bullet inserter was tried, but the cage was still not straight.Another implant had to be opened, which loaded correctly.Surgeon was getting s1 nerve root irritation with neuromonitoring so implanted and removed second implant.Had to get ct scan and navigate remaining screws.It was also reported that a viper prime screwdriver was not able to release screw and stylet was bent and had to be cut.There was a surgical delay of ten (10) minutes.Patient is recovering well.Concomitant devices: screws (part: unknown, lot: unknown, quantity: unknown).This report is for a viper prime inserter handle.This is report 3 of 6 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.H3, h4, h6: a review of the receiving inspection (ri) for viper prime inserter handle was conducted identifying that lot number: mf4292702 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 23 mar 2018 with no discrepancies.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.Visual inspection: a viper prime inserter assembly was returned to us customer quality (cq), all four of its main components were returned assembled to one another.The assembly consisted of: viper prime inserter carrier (part#: 286750033 / lot#: mf4283703), viper prime insert drive tube (part#: 286750034 / lot#: ), viper prime inserter handle (part#: 286750032, lot#: mf4292702) and viper prime inserter shaft (part#: 286750031, lot#: mf4302702).The prime stylet depth adjustor and viper prime stylet were also received assembled into the inserter assembly.There was no damage evident on the exterior of the assembly.The inserter handle had no damage to note.Functional test: when rotating the handle, the stylet was successfully withdrawn or extended.The inserter assembly was successfully disassembled by loosening the set screw, and then separating the individual components.Each component was successfully disassembled from one another thus the overall complaint was not confirmed.There was no evidence of a device disassembly issue.Can the complaint be replicated with the returned device(s)? no; device disassembled successfully.Dimensional inspection: dimensional inspection was not performed as the reported condition could not be confirmed and no damage could be identified that would contribute to the complaint condition.Document/specification review: drawing(s) reviewed: current & manufactured revisions.Conclusion: the overall complaint was not confirmed for the received viper prime inserter handle as the device was successfully disassembled.The handle successfully withdrew/extended the stylet when rotated.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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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.H10 additional narrative: h3, h4, h6: a viper prime inserter assembly was returned to us cq, all four of its main components were returned assembled to one another.The assembly consisted of: viper prime inserter carrier (part # 286750033 / lot # mf4283703), viper prime insert drive tube (part # 286750034 / lot # ), viper prime inserter handle (part # 286750032, lot # mf4292702) and viper prime inserter shaft (part # 286750031, lot # mf4302702).The prime stylet depth adjustor and viper prime stylet were also received assembled into the inserter assembly.There was no damage evident on the exterior of the assembly.The inserter handle had no damage to note.When rotating the handle, the stylet was successfully withdrawn or extended.The inserter assembly was successfully disassembled by loosening the set screw, and then separating the individual components.Each component was successfully disassembled from one another thus the overall complaint was not confirmed.There was no evidence of a device disassembly issue.Dimensional inspection was not performed as the reported condition could not be confirmed and no damage could be identified that would contribute to the complaint condition the overall complaint was not confirmed for the received viper prime inserter handle as the device was successfully disassembled.The handle successfully withdrew/extended the stylet when rotated.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 history lot a review of the receiving inspection (ri) for viper prime inserter handle was conducted identifying that lot number mf4292702 was released in a single batch.Batch1: units were released on 23 mar 2018 with no discrepancies.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 ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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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Search Alerts/Recalls
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