MAUDE Adverse Event Report: DEPUY IRELAND UNK-VELYS-SASI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNK-VELYS-SASI

Device Problem Device Slipped (1584)

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

Event Date 04/25/2022

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.Concomitant medical devices and therapy dates, base station device, array set knee device and a saw blade device, (b)(6) 2022.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Catalog number, serial number, lot number and gtin are unknown.Brand name is unknown.Device manufacture date is unknown.

Event Description

It was reported that during a total knee arthroplasty surgical procedure, while making the posterior condyle cut, it was observed that the saw blade device went dead and the system terminated the application.It was reported that no error code was presented and the surgeon completed the case with manual instrumentation.It was reported that following the same procedure, the robotic assisted saw interface device was found to be very loosely attached to the arm.It was reported that there was a 30 minute delay in the surgical procedure.It was reported that the device was also being used with the array knee device and the base station.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.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK-VELYS-SASI
• 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: 14371224
• MDR Text Key: 291473914
• Report Number: 1818910-2022-08688
• Device Sequence Number: 1
• Product Code: OLO
• 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
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-VELYS-SASI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• 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