MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 228152 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2024 |
Event Type
malfunction
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Event Description
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It was reported by the healthcare professional in china that during a knee arthroscopy procedure on (b)(6) 2024, it was observed that the truespan 24 degree peek device could not fire.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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.Device was used for treatment, not diagnosis.Udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture 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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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.Device was used for treatment, not diagnosis.H10 additional narrative: d4, h4: the expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).
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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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary = > the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection and functional test of the returned device.Visual inspection found that truespan 24 degree peek had both implants deployed.It does not show structural anomalies.The plates and the suture are in good conditions.The red trigger was found in a normal shape.No other anomalies could be observed.A functional test was performed to the trigger.The trigger was activated several times, no obstruction or difficulties while deploying were found.It was verified that the pusher shaft tip is sliding out completely from the applier needle.The overall complaint was unconfirmed as the observed condition of the truespan 24 degree peek would not contribute to the complained device issue.¿ based on the investigation findings, the potential cause could be traced to the procedural variables, such handling of the device or product interaction during procedure.As per ifu: use instructions are provided, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
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