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Model Number 214141 |
Device Problems
Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2022 |
Event Type
malfunction
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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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Reporter is a j&j sales representative.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 sales rep that during a rotator cuff repair procedure on (b)(6)2022, it was observed that the plastic flag on the expressew iii needle device fell off then the needle got jammed, and then it was successfully released.Another like device was used to complete the procedure with a delay of two minutes.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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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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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.Investigation summary: according to the information received, it was reported that during a rotator cuff repair, the plastic flag of the expressew iii needle fell off.The needle got jammed, and then it was successfully released.Another device was used to complete the procedure.The complaint device was received in a completely sealed pouch.Upon visual inspection, it was observed that the needle has no structural anomalies, the white plastic flag was found incorrectly positioned, it is 1mm approximately closer to the proximal end, the flag is not seated in its corresponding mark on the shaft.The needle was tested on a expressew gun, the needle loading was not possible since the needle groove is not getting inside the deployer mechanism.This complaint is confirmed.Complaints have been filed regarding the expressew iii needle as part of the expressew iii autocapture flexible suture passer system.This system is indicated for passing suture through tissue in open or arthroscopic surgery.Complaint was received due to the incorrect position of the plastic flag at the proximal part of the expressew needle, and this flag is used to properly load or unload the needle and used to position the needle properly within the expressew iii re-usable instrument.Depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Device history lot: a manufacturing record evaluation was performed for the finished device 66895, and no non-conformances were identified.
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Search Alerts/Recalls
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