Model Number 228143 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Tissue Damage (2104); No Code Available (3191)
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Event Date 06/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported by distributor via email that during an anterior cruciate ligament reconstruction + meniscus suture, three meniscal applier, omnispan, did not fire the needle, two omnispan meniscal repair system/0 degree were opened and fired, but then stopped.Then they opened a omnispan meniscal repair system/12 degree which fired three needles but they did not hold.Shots were made with the applicator but the needles did not hold to the meniscus.The surgery was converted to open to solve problem.No surgical delay or patient consequences reported.Devices were discarded.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: investigation summary = > the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (l513127), and no non-conformances were identified.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.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.- will the patient¿s hospital/rehab stay be prolonged beyond what was anticipated? was the hospital stay prolonged? there was no need.- did the patient receive intra-op/post op medications beyond the standard antibiotics/steroids/pain medications due to converting to open procedure? not applicable.- any medical complications due to this conversion ¿ unanticipated infection, prolonged anesthesia causing patient distress? not applicable.
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Search Alerts/Recalls
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