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

Model Number 4515-70-107

Device Problem Device Slipped (1584)

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

Event Date 04/28/2022

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.

Event Description

It was reported during a total knee arthroplasty procedure, it was observed that the robotic assisted solution array clamp device had a wing nut that was loose and not securing the array.It was reported that this issue was discovered when during the case the clinician bumped the array and the array had movement.It was reported that the surgeon had to bail on the case and go to a manual procedure.It was reported that there was a slight delay in the procedure to go to manual.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization reported.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.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.H6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: the actual device was returned for evaluation.During evaluation it was determined that the device functional fit check was found to be secure.Visual inspection of the returned device found no damage that would be expected to contribute the reported condition.Saw bone resections were made using the returned devices and it was found that there was a secure fit and no movement during the cuts.Therefore, the reported condition could not be confirmed and no problem was found.The assignable root cause could not be determined.

• Brand Name: VELYS ARRAY CLAMP
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 14362635
• MDR Text Key: 291475933
• Report Number: 1818910-2022-08418
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519379
• UDI-Public: 10603295519379
• 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,Followup,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-107
• Device Catalogue Number: 451570107
• Device Lot Number: J43502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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