MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 4515-70-102

Device Problems Device Slipped (1584); Intermittent Loss of Power (4016)

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

Event Date 03/16/2022

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. Udi: (b)(4). Concomitant medical devices and therapy dates, saw interface devices, base station and satellite station device. (b)(6) 2022.

Event Description

This is report 3 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 handpiece device was stuttering on every cut. It was reported that there was play between the saw interface right (sasi) and the saw handpiece. The reporter stated that the devices were swapped out. The reporter stated that the surgeon ¿touched up¿ the tibia after the swap out. Swapping out the saw interface and the saw handpiece resolved the observed stuttering. After the surgical procedure, it was reported that the left saw interface and the saw handpiece were tested and it was observed that there was even more play between the device. It was reported that the surgeon manually completed the cuts. It was reported that there was a 5 to 10 minute delay in the surgical procedure. It was reported that the devices were being used with a robotic assisted base station and satellite station device. There was patient involvement. There were no reports of 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 HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthpaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 13863153
• MDR Text Key: 288511858
• Report Number: 1818910-2022-05175
• 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: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4515-70-102
• Device Catalogue Number: 451570102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown