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Model Number 219495 |
Device Problems
Device Contamination with Body Fluid (2317); Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
Event Type
malfunction
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Event Description
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It was reported by the customer in australia that during an unknown surgery on (b)(6) 2022, it was observed that the depth markings on the healix knotless awl, 3.4mm have worn off.During in-house engineering evaluation of the photo provided by the customer, it was determined that the depth laser etch mark was faded and it could be observed biological residues (blood) on the device.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.Udi: (b)(4).Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, the photo shows a healix knotless awl 3.4mm with the depth laser etch mark faded and it could be observed biological residues (blood) on the device.Hands on analysis should provide the evidence necessary to confirm the root cause.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint can be confirmed.Since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to a laser etch mark to faded.However, it cannot be conclusively affirmed.As per ifu, clean instruments as soon as possible after use.If cleaning must be delayed, wet the instruments in a compatible liquid solution to prevent drying and encrustation of surgical soil.Avoid prolonged exposure to saline to minimize the chance of corrosion.Remove excessive soil with a disposable wipe.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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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.D9, h3, h6: 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: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection was found use wear on the device.It could be observed laser etch mark faded.Finally, no structural anomalies were found on the device.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.Since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to a laser etch mark to faded.However, it cannot be conclusively affirmed.As per instructions for use (ifu), clean instruments as soon as possible after use.If cleaning must be delayed, wet the instruments in a compatible liquid solution to prevent drying and encrustation of surgical soil.Avoid prolonged exposure to saline to minimize the chance of corrosion.Remove excessive soil with a disposable wipe.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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