Model Number 4515-70-105 |
Device Problem
Device Slipped (1584)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
|
|
Event Description
|
It was reported that during a total knee arthroscopy surgical procedure, it was observed that the robotic assisted saw interface left (sasi) had play with the saw.It was reported that the tab on the saw that connects to the sasi showed wear marks and there was play between the saw and the sasi.It was also reported that the back side of the sasi clamp that connects the sasi to the robot was loose.It was reported that it was part of the clamp that squeezes as the part that is loose.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
|
|
Event Description
|
It was reported that during a total knee arthroscopy surgical procedure, it was observed that the robotic assisted saw interface left (sasi) had play with the saw.It was reported that the tab on the saw that connects to the sasi showed wear marks and there was play between the saw and the sasi.It was also reported that the back side of the sasi clamp that connects the sasi to the robot was loose.It was reported that it was part of the clamp that squeezes as the part that is loose.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.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 the device has been evaluated, a supplemental medwatch report will be sent accordingly.
|
|
Manufacturer Narrative
|
Product complaint (b)(4).Investigation summary: after multiple requests, the customer has not returned the device for evaluation / repair to any jnj site and therefore the complaint cannot be confirmed, and no conclusion can be drawn at this time.The complaint will be reopened upon receiving the device for repair from the customer.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Manufacturer Narrative
|
Product complaint #(b)(4).Investigation summary: examination of the returned device did not confirm the complaint.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.B5: the event description has been updated to include the addition of a robotic assisted saw handpiece device and additional saw interface device.The reported condition of connection is being addressed through capa.
|
|
Event Description
|
This is 1 of 3 for the same event.It was reported that during a total knee arthroscopy surgical procedure, it was observed that the robotic assisted saw interface left (sasi), right and left, had play with the robotic assisted saw handpiece device.It was reported that the tab on the saw that connects to the sasi showed wear marks and there was play between the saw and the sasi.It was also reported that the back side of the sasi clamp that connects the sasi to the robot was loose.It was reported that it was part of the clamp that squeezes as the part that is loose.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Upon further evaluation of the device it was determined that the complaint sample was forwarded to product development for further evaluation.Visual inspection and trial fit with mating parts were performed.The actual device was evaluated.Visual inspection was performed and light wear marks were observed consistent with light use, as the mating interface is a steel-on-steel connection.The device was observed to be in good condition.It was observed that the springs on the device were slightly deformed, but this did not impact use.It was observed that clamp articulation was very smooth for the device and the toggle in the saw clamps when open was consistent with nominal design.The device was test fit with 3 different saw handpieces devices to assess the clamped connection.It was observed that parts were very rigid when connected and there was not toggle in the connection.The reported condition was not confirmed.Therefore, an assignable root cause was not determined.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|