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

Model Number 4515-70-107

Device Problems Appropriate Term/Code Not Available (3191); Premature Separation (4045)

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

Event Date 10/14/2021

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. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. The reporter was not able to provide the associated lot number for this event so the lot numbers provided were j43052 and j43054 and it is unknown which of the two devices is associated with the reported event.

Event Description

It was reported that during surgery that the array clamp device disassociated from the array. It was also reported that the array clamp appeared to have loosened. It was reported that there was a 40 minute surgical delay. It was reported that the user went to manual instrumentation following the event. There were no reports of 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 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: 12805026
• MDR Text Key: 280705480
• Report Number: 1818910-2021-24965
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/12/2021
• 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: J43052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• 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