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

Model Number 4515-70-106

Device Problems Device Slipped (1584); Premature Separation (4045)

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

Event Date 01/04/2022

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. The actual device has been returned and is currently pending evaluation. Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly. Concomitant medical devices and therapy dates, saw handpiece device, (b)(6) 2022. Udi: (b)(4).

Event Description

This is report 1 of 2 for the same event. It was reported that during the procedure and while making the anterior femoral cut, the robotic assisted saw interface right (sasi) device was loose and not clamping tight to the saw handpiece device. It was further observed that the saw handpiece was connecting loosely to the sasi. It was further reported that the right sasi came unlatched during the cut and it was clamped back quickly with no impact to surgery. It was reported that the sasi was tested with other saw handpiece devices and found the connection to be loose. Additionally, the saw handpiece was tested with other sasi's and found the connection to be loose. Other sasi's with the other saw handpiece device clamped securely. 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 INTERFACE RIGHT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND UC; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthpaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 13384453
• MDR Text Key: 284621857
• Report Number: 1818910-2022-00705
• 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: Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4515-70-106
• Device Catalogue Number: 451570106
• Device Lot Number: J44179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unkown