Model Number 3010-19-010 |
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 11/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: 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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It was reported that on (b)(6) 2021, during a lumbar fusion surgery, the 8mm tip/tap was inserted in bone using the dss power hand piece.As the pedicle was being tapped, the array became locked to the tap.Once this happened, the array would rotate 360 degrees with the tap.The lock array also locked onto the viper prime driver.Both instruments were used on power.There was a surgical delay of twenty (20) minutes.No visible fragments were noticed.Patient status is unknown.The procedure was successfully completed.This report is for one (1) navigation enabled instruments viper prime driver.This is report 1 of 1 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 nav driver was conducted identifying that lot number mf4418101 was released in three batches.Batch 1: lot qty of (b)(4) units were released on 27 oct 2020 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on 21 oct 2020 with no discrepancies.Batch 3: lot qty of (b)(4) units were released on 27 oct 2020 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.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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Search Alerts/Recalls
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