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

Model Number 4515-70-105

Device Problem Device Slipped (1584)

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

Event Date 04/11/2022

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.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant medical devices and therapy dates, robotic assisted saw assembly saw interface right devices, (b)(6), 2022.Udi:(b)(4).

Event Description

This is report 1 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 assembly saw interface left (sasi) clamp was loose and not performing the primary function.It was reported that the cut on the tibia could not be made and there was a lot of shutting down and stopping.It was reported that looking at the saw clamp it had no pressure and took little to no pressure to lift it up and not enough force to stay latched.It was also reported that two right sasi clamps seemed to lack the capacity to stay locked properly and could pop loose during surgeries as well, and had the same latching weakness as the left sasi.It was reported that there were no delays in the surgical procedure and the case was successful.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.

Event Description

This is report 2 of 4 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that the robotic assisted saw assembly saw interface left (sasi) clamp was loose and not performing the primary function.It was reported that the cut on the tibia could not be made and there was a lot of shutting down and stopping.It was reported that looking at the saw clamp it had no pressure and took little to no pressure to lift it up and not enough force to stay latched.It was also reported that two right and one left sasi clamp seemed to lack the capacity to stay locked properly and could pop loose during surgeries as well, and had the same latching weakness as the left sasi.It was reported that there were no delays in the surgical procedure and the case was successful.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.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.Corrected data b5: additional information was received on may12th, 2022 that an additional device was involved in this event.Therefore, the event description as been updated to 1 of 4 for the same event and description updated to include additional robotic assisted saw interface left device.

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.H10 additional narrative: investigation summary: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had a loose connection of the sasi clamp to the saw handpiece.Therefore, the reported condition was confirmed.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the failure mode were found.The issue related to a the loose connection has been escalated to a capa.The assignable root cause could not be established.

• Brand Name: VELYS SAW INTERFACE LEFT
• 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: 14251891
• MDR Text Key: 290449469
• Report Number: 1818910-2022-07151
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519461
• UDI-Public: 10603295519461
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-105
• Device Catalogue Number: 451570105
• Device Lot Number: J44180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1