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

Model Number 4515-70-105

Device Problem Device Slipped (1584)

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

Event Date 03/16/2022

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, saw interface device, saw handpiece device, base station and satellite station device.(b)(6) 2022.

Event Description

This is report 1 of 3 for the same event.It was reported that during a total knee arthroscopy surgical procedure, it was observed that the robotic assisted saw handpiece device was stuttering on every cut.It was reported that there was play between the saw interface right (sasi) and the saw handpiece.The reporter stated that the devices were swapped out.The reporter stated that the surgeon ¿touched up¿ the tibia after the swap out.Swapping out the saw interface and the saw handpiece resolved the observed stuttering.After the surgical procedure, it was reported that the left saw interface and the saw handpiece were tested and it was observed that there was even more play between the device.It was reported that the surgeon manually completed the cuts.It was reported that there was a 5 to 10 minute delay in the surgical procedure.It was reported that the devices were being used with a robotic assisted base station and satellite station device.There was patient involvement.There were no reports of 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

Product complaint (b)(4).Investigation summary: after multiple requests, the customer has not returned the device for evaluation / repair to any jnj site.And therefore, the complaint cannot be confirmed.And no conclusion can be drawn at this time.The complaint will be reopened upon receiving the device for repair from the customer.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device 451570105/ j44180 number.And no non-conformances / manufacturing irregularities were identified.

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.The actual device was not returned for evaluation.As no device associated with this report was received for examination, the investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Therefore, the reported condition was not confirmed.A root cause was not determined.Although the device was not returned, the reported condition of connection issue is being addressed through capa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VELYS SAW INTERFACE LEFT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthpaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 13863192
• MDR Text Key: 288677664
• Report Number: 1818910-2022-05183
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519461
• UDI-Public: 10603295519461
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-105
• Device Catalogue Number: 451570105
• Device Lot Number: J44180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 05/20/2022; 06/30/2022
• Supplement Dates FDA Received: 05/23/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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