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

Model Number 4515-70-102

Device Problem Premature Separation (4045)

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

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. The device serial or lot number was unknown; therefore, udi: (b)(4). Unknown. Device manufacture date is unknown. The device serial or lot number is unknown. Concomitant medical devices and therapy dates, robotic assisted satellite station and array set, (b)(6) 2022. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a total knee arthroscopy procedure and while in the middle of making the femur cuts, the array device "popped" off of the robotic assisted saw handpiece near the blade. It was reported that the device was also being used with a robotic assisted satellite station. It was further reported that it was verified the array attached into the saw properly by hearing and feeling it click into place. It was reported that there were no delays in the surgical procedure. 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 HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY IRELAND UC; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: amy hendrickson ; 700 orthpaedic dr.; warsaw, IN 46581 ; 5743674841
• MDR Report Key: 13953873
• MDR Text Key: 288288521
• Report Number: 1818910-2022-05832
• 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
• Report Date: 03/30/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/30/2022
• 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: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown