DEPUY SPINE INC VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING 5MM 30-60MM; TAP, BONE
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Model Number 286715500 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2023 |
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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Ivestigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 japan as follows: it was reported that on (b)(6) 2023, during a plif for the lumbar stenosis before sterilization, stein was found in the hollow part of the devices.The devices were delivered on the operation day, and the surgeon determined that it would take time to clean.Therefore, other same devices were used.Procedure was completed successfully without any surgical delay.No further information is available.This report is for one (1) viper 2 system tap, cannulated and self-drilling 5mm 30-60mm plus or minus 0.24 percent.This is report 2 of 2 for complaint (b)(4).
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