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

Model Number 4515-70-106

Device Problem Device Slipped (1584)

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

Event Date 11/11/2021

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, it was observed that excessive movement was experienced with the robotic-assisted saw solution saw interface right device and the array was not visible.The case was completed with no issues.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.

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.The device serial or lot number was unknown; therefore, udi: (b)(4).Device manufacture date is unknown.

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.The device serial or lot number was unknown; therefore, udi: (b)(4).Device manufacture date is unknown.

Event Description

It was reported that during a surgical procedure, it was observed that excessive movement was experienced with the robotic-assisted saw solution saw interface right device and the array was not visible.The case was completed with no issues.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: 13046685
• MDR Text Key: 285932725
• Report Number: 1818910-2021-28233
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519478
• UDI-Public: 10603295519478
• 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: Other
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-106
• Device Catalogue Number: 451570106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2021
• 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: Unknown
• Patient Sequence Number: 1