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Catalog Number 210813 |
Device Problems
Migration or Expulsion of Device (1395); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
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Patient Problems
Tissue Damage (2104); No Consequences Or Impact To Patient (2199)
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Event Date 12/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 by the affiliate in the (b)(6) that the screw tip of the gryphon p br ds anchor w/oc implant device was deformed.It was not reported if there was a delay in the surgical procedure, or if a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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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 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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Additional information received from the affiliate on 01/11/2019 stating that the adverse event was a possible pullout of implant from the bone on (b)(6) 2018.The case was completed by opening another stock.Additional information was received by the affiliate on 01/15/2019 stating that the event occurred inta-op.There was a surgical delay of 10 minutes.There was no patient harm due to this delay.The case was completed with another readily available device.The affiliate also stated that the surgeon was not off-axis while they were using the implant and there was no debris left in the patient.The same bone hole was used to complete the procedure.
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Manufacturer Narrative
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(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, a non-conformance search was conducted and no non-conformances were identified for this part number (b)(4), lot number (l189929) combination.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(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 additional information should become available, a supplemental medwatch will be submitted accordingly.Subsequent follow-up with the customer, additional information was received.The reporter stated that the complaint product has been discarded and will not be available for return.
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Search Alerts/Recalls
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