MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW INTERFACE RIGHT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-106

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

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

This is report 2 of 2 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that the robotic assisted saw device was stuttering/lots of stopping and starting.It was further reported that there was lots of play between the connection of the interface left and right (sasi) and the saw device.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.It was reported that new sasis, the issue was resolved.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.It was reported that the surgical procedure was completed.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.Additional information was received that stated a third device was involved.Therefore, fields b5, d1, d4 have been updated to reflect.The event description was updated to include an additional saw interface device right and to remove the saw interface device left.It was also updated to be 2 of 3 for the same event.D1 and d4: the device brand name, catalog number, lot number and udi were updated accordingly.The device udi has also been updated.Udi: (b)(4).D11, concomitant medical devices and therapy dates, saw interface devices right and saw handpiece device, unknown.

Event Description

This is report 2 of 3 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that the robotic assisted saw device was stuttering/lots of stopping and starting.It was further reported that there was lots of play between the connection of the interface right (x3) and the saw device.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.It was reported that new sasis, the issue was resolved.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.It was reported that the surgical procedure was completed.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.The device was returned for evaluation, along with a video.Evaluation of the device and video determined, that the sasi components were loose.Therefore, the reported condition was confirmed.A manufacturing record evaluation was performed, for the finished device were no non-conformances.That would be expected to cause or contribute to the event.The issue related to the loose connection has been escalated to a capa.The assignable root cause could not be established.

• Brand Name: VELYS SAW INTERFACE RIGHT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 14371047
• MDR Text Key: 291472137
• Report Number: 1818910-2022-08248
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519478
• UDI-Public: 10603295519478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-106
• Device Catalogue Number: 451570106
• Device Lot Number: J44630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1