Model Number 219335 |
Device Problems
Degraded (1153); Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2022 |
Event Type
malfunction
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Event Description
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This is report 2 of 6 for (b)(4).It was reported by sales rep that the acorn reamer thin shaft device was really dull and not sharp.It was further reported that the lot number could no longer be read.There was no patient nor procedure involvement 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).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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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 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.H10 additional narrative: investigation summary =the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed marks of wear on the device and damage was observed in the distal part.The distal part showed that the device had been heavily used and it was found dull.Also, the laser marks were faded; besides the laser line is not visible.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.It is determined that the reusable instrument is worn from repeated use and servicing, this failure can be attributed to normal field wear.The possible root cause of the damage in the tip can be attributed when the device being dropped/ mishandled on hard surface causing the weld to fail.Besides, possibility of mishandling, we cannot discern a root cause for this failure mode.As per ifu, inspect the instruments before use for integrity and compatibility in order to ensure proper functionality and safety.Place the instrument in the appropriate location within the sterilization tray.During the cleaning process, inspect the instruments after each cleaning cycle to ensure proper functionality function and safety.If you suspect a problem, set aside the instrument for repair.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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Search Alerts/Recalls
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