|
Catalog Number 214601 |
Device Problems
Break (1069); Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/09/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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) incomplete.The expiration date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
|
|
Event Description
|
It was reported that during subscapularis repair procedure, it was observed that the penetrating grasper 35° up device was broken; and that the jaws would not close.Another like device was used to complete the procedure with an unspecified delay.There were no adverse consequences to the patient.No additional information was provided.
|
|
Manufacturer Narrative
|
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.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.
|
|
Manufacturer Narrative
|
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 for evaluation.Depuy synthes then conducted visual inspection of the devices received.The device was received and evaluated.When performing the visual inspection, it could be observed that the device comes in used condition, it was identified that the device has the jaw loose, it could not be closed/opened as intended.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the arthro grasper pen 35 up *ea would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life.As per ifu-107066 end of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.Visually inspect the instrument and check for damage and wear.Jaws and teeth should align properly.Cutting edges should be free of nicks and have a continuous edge.Therefore, it has been determined that no corrective and/or preventative action is required.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.Device history review: a manufacturing record evaluation was performed for the finished device lot number 23c03, and no non-conformances were identified.
|
|
Search Alerts/Recalls
|
|
|