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

Catalog Number 451570105

Device Problem Device Slipped (1584)

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

Event Date 03/26/2024

Event Type  malfunction  

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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).

Event Description

It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic assisted saw interface left (sasi) device the lever holding the saw in the sasi came loose and came open after the distal cut was completed terminating the clinical application.The procedure was transitioned to manual instrumentation and there was no negative impact to the patient.It was reported that there were no delays in the surgical procedure.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

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.D9, h3, 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.H11 additional narrative: investigation summary: visual analysis found no damage or visual defects with the device.The overall appearance of the device shows signs of multiple uses in a clinical setting.Functional testing found that the sasi saw clamp successfully assembled and disassembled with the mating saw handpieces.However, while conducting functional tests with the production equivalent saws attached, the assessment revealed a mechanical play or looseness between the saw-sasi clamp mechanism and the main body of the sasi in the direction parallel to the saw blade.Despite the presence of looseness, there was no undesired movement or play noted between the saw-sasi clamp mechanism and the saw.The issue related to undesired movement has been escalated to a capa.The overall complaint could not be confirmed, however, one likely contributing factor is during use, the user accidentally snagging the clasp causing the clamping mechanism to disengage.The assignable root cause was due to use and design.

• Brand Name: VELYS SAW INTERFACE LEFT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46581
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18995867
• MDR Text Key: 338906293
• Report Number: 1818910-2024-07038
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

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 Catalogue Number: 451570105
• Device Lot Number: J44631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/30/2024; 05/23/2024
• Supplement Dates FDA Received: 05/06/2024; 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1