MAUDE Adverse Event Report: DEPUY IRELAND UC VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-107

Device Problems Mechanical Problem (1384); Premature Separation (4045)

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

Event Date 02/03/2022

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, array clamp devices and satellite station device, (b)(6) 2022.

Event Description

This is report 1 of 5 for the same event. It was reported that during a surgical procedure, it was observed the femoral cuts were off while the satellite station device was in use. Following the surgery, it was reported that the clinician pulled on the femoral arrays and observed that the array devices detached from the array clamps without pressing the button release on the array clamp devices. It was reported that there were a total of four array clamps that released the array without pressing the button. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization and the surgery was completed successfully. All available information has been disclosed. Multiple attempts have been made to obtain additional information. No additional information has been received. If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: VELYS ARRAY CLAMP
• 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: 13621279
• MDR Text Key: 286377645
• Report Number: 1818910-2022-03760
• 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,Followup,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4515-70-107
• Device Catalogue Number: 451570107
• Device Lot Number: J43054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown