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| Model Number 228151 |
| Device Problem
Mechanical Jam (2983)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/19/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).The expiration date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported by the affiliate in (b)(6) that during a meniscal repair procedure on (b)(6) 2021, it was observed that the anchor device did not come out and remained stuck in the needle.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
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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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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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: d4, h4; the expiration and manufacture dates were reported as unknown on the initial report.Both fields have been updated accordingly.Therefore, udi: (b)(6).Investigation summary: the complaint device was not returned after multiple attempts for device return, 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 (7l11356), and no non-conformances were identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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: investigation summary according to the information provided, it was reported that the truespan 12 ° ref: 228151 lot 7l11356.Which at the time of use in the meniscus the peek point remained attached to the needle and did not fix to the tissues.The device was received and evaluated.When performing the visual inspection, it could be observed that the first plate was not fully deployed due to a very small part of the implant remains inside the applier needle.The covering sleeve was removed to verify the presence of the second plate and the sutures, it was found that the second plate is inside of the silicon sleeve that keeps the plates inside the needle.No structural anomalies that can interfere with a full deployment were found.The functional test was performed to the second plate.The applier needle was introduced into a soft tissue simulator, the red trigger was fully squeezed, the second plate was successfully deployed, no obstruction or difficulties while deploying.It was verified that the pusher shaft tip is sliding out completely from the applier needle.A manufacturing record evaluation was performed for the finished device 7l11356 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection and the functional test results, this complaint can be confirmed.The possible root cause for this issue can be attributed to the procedural variables, such handling of the device or product interaction during procedure; the operator did not squeezed the red trigger to its fully position.As per ifu 113244, at desired depth, fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.The implant is fully deployed when you hear an audible ¿click¿.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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Search Alerts/Recalls
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