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.

• 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
• 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

• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

0 Patients were 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

• 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: 04/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No