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

Catalog Number 451570106

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

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

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: the actual device was returned for evaluation.It was found that the overall appearance of the device showed signs of normal wear from multiple uses in a clinical setting.There was also burnishing noted on the saw contact regions of the sasi clamp pads consistent with repeated assembly and disassembly.While conducting functional tests with the production equivalent saws attached, the assessment revealed a toggle between the saw-sasi clamp mechanism and the main body of the sasi in the direction parallel to the saw blade.Since the device was not found to be stuck the reported condition was not confirmed.Despite the toggle, there was no undesired movement or play noted between the saw-sasi clamp mechanism and the saw.The issue related to the looseness is being addressed through a capa.The assignable root cause was due to design.(b)(4).

Event Description

It was reported that the robotic assisted saw interface device right saw clamp was so tight that they were unable to open and close it.During an in-house engineering evaluation, it was determined that the device had mechanical play between the saw-sasi clamp mechanism and the main body of the sasi in the direction parallel to the saw blade.It was not reported if the device was used in surgery, or if there was patient involvement.The exact date of this event is unknown.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.

• Brand Name: VELYS SAW INTERFACE RIGHT
• 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: 18919129
• MDR Text Key: 337844932
• Report Number: 1818910-2024-05893
• 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: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2024

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: 451570106
• Device Lot Number: J44925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1