DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number 210712 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
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.Device was used for treatment, not diagnosis.H10 additional narrative: 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 submitted accordingly.
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Event Description
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It was reported from china that during a rotator cuff repair procedure, it was observed that the anchor on the lupine br ds w/orthcrd device broke off.Another like device was used to complete the procedure.There were no adverse consequences to the patient reported 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 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.Device was used for treatment, not diagnosis.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted 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 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.Investigation summary: both photo and the complaint device were received and evaluated.The photo investigation revealed that lupine br ds w/orthcrd is in used condition.The anchor is broken in half.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found that the device is in used condition.The anchor was found broken in half.The overall complaint was confirmed as the observed condition of the lupine br ds w/orthcrd would contribute to the complained device issue.Based on the investigation findings, the potential root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure, bending force may was applied to the device at the moment of insertion; as per ifu: do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.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 complaint condition.As part of depuy synthes 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.Device history review: a review of the batch manufacturing records was conducted on finished lot number 166l149; and no related non-conformances were identified.
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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.D4, h4: the expiration date and device manufacture date have been updated accordingly.Therefore, udi: (b)(4).
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Search Alerts/Recalls
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