DEPUY SPINE INC VIPER SYSTEM FENESTRATED SCREW MIS CANNULA 16G X 228MM; DISPENSER, CEMENT
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Model Number 279726508 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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.Reporter is a synthes employee.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.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 poland (b)(6) an event as follows: it was reported that on an unknown date that two products were broken.This report is for one (1) viper system fenestrated screw mis cannula 16g x 228mm.This is report 1 of 2 for (b)(4).
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Event Description
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Additional event information it was reported on an unknown date the patient underwent for a procedure.During the procedure, two products were broken.It was unknown how it was occurred.It was unknown if the surgery completed successfully.The patient outcome was unknown.
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Manufacturer Narrative
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Product complaint # (b)(4).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.Updated additional event information 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.H3, h6: a review of the receiving inspection (ri) for fen mis cannula was conducted identifying that lot number lc33104 was released in a single batch.Batch1: lot qty of (b)(4) units were released on may 14, 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 fen mis cannula strl (part# 279726508, lot# lc33104 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the small tube has broken off the ferrule.The broken piece was also returned.No other issues were noted with the device.Dimensional inspection: major external diameter: conforming; minor internal diameter: conforming; caliper.Dwg-887012872 rev.A: external diameter: specification: 1.68 ±0.03mm, measured: 1.69mm (conforming); internal diameter: specification: 1.52 ±0.03mm, measured: 1.53mm (conforming); caliper ca122p.Document/specification review: the following drawings (current and manufactured to) were reviewed: expedium adult - fenestrated cannula - overmold; expedium adult - fenestrated cannula sub-assembly; expedium adult - fenestrated cannula - large tube; expedium adult - fenestrated cannula - small tube; expedium adult - fenestrated cannula - ferrule; no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the fen mis cannula strl (part# 279726508, lot# lc33104 qty# 1).While a definitive root cause could not be identified for the reported problem, it is possible that the device might have encountered unintended forces.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 upon these results, 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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