Model Number 286750033 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2020, the patient underwent for a surgery.During the surgery, the viper prime navigated driver shaft slightly loosened itself from the driver tube.The stylus not fully going out of the screw as expected (5 mm).The red handle was not turning smoothly (gripped).The stylus was not fully extending outside the screw as expected.Not a problem of loose shaft onto tube.The surgery was completed successfully with 25 minutes delay.There was no patient consequence.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown ); unknown hammer/mallet (part# unknown, lot# unknown, quantity unknown ).This report is for (1) viper prime inserter carrier.This is report 4 of 4 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.H3, h4, h6: a review of the receiving inspection (ri) for viper prime inserter carrier was conducted identifying that lot number mf4344003 was released in a single batch.- batch1: lot qty of (b)(4) units were released on 27-mar-2019 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: the assembly of viper prime navigated inserter including viper prime inserter handle (part.No: 286750032, lot.No: mf4328001), viper prime inserter carrier (part.No: 286750033, lot.No: mf4344003), prime nav inserter drive tube(part no: 286750042 & lot no: mf4376208) and viper prime nav shaft assy (part no: 286750131n & lot no: mf4283712) was received at us customer quality (cq) in assembled condition.Upon visual inspection at cq, no visual damages were observed on the received devices except normal wear which would not contribute to the reported complaint condition.Functional test: the complete functional testing of the received device was unable to perform as all the mating devices relevant to the complaint condition were not returned at cq.The received viper prime navigator inserter assembly was able to be disassembled and re-assembled as intended.The received viper prime inserter carrier (part.No: 286750033, lot.No: mf4344003) was disassembled and re-assembled with prime nav inserter drive tube(part no: 286750042 & lot no: mf4376208) without any issues.Can the complaint be replicated with the returned devices? unable to perform dimensional inspection: the dimensional inspection was not performed since there was no defect identified with the device and received devices were able to be re-assembled as intended.Document/ specification review: the following drawings reflecting the current and manufactured revisions were reviewed during the investigation: -viper prime inserter threaded carrier no design issues or discrepancies were noted during the investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for the received device as no visual damages were observed on the device and it was able to be disassembled and re-assembled with the mating devices as intended.No definitive root cause could be determined based on the provided information.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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Event Description
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Only the shaft was replaced.
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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: b5: updated.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H6: codes updated.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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