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Catalog Number 210712 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 10/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.(b)(4).
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Event Description
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It was reported by the sales rep via phone that the lupine loop rapide anchor w/orthocord ds could not be used due to the failure of the lupine - spiral fluted drill bit which was causing metal shavings in the procedure and they were successfully removed.No patient consequences nor surgical delay.Replacement of both devices were requested.Additional information received from the sales representative reported the lupine loop rapide anchor with orthocord pulled out of the bone.It was reported the case was completed by using a new drill bit, drilling a new bone hole, and utilizing a new lupine anchor.The sales representative reported all alternative products were readily available and additional surgical intervention is not planned.
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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.Awareness date reported on initial report as october 04, 2019 but should have been october 22, 2019.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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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.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.Investigation summary = > the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [3l18785] number, and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Udi:(b)(4).
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Search Alerts/Recalls
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