MAUDE Adverse Event Report: DEPUY IRELAND UC 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 12/28/2021

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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Device manufacture date is unknown.The device serial or lot number is unknown.Concomitant medical devices and therapy dates, base station device and fixation pin device and array device, (b)(6) 2021.The device serial or lot number was unknown; therefore, udi: (b)(4).

Event Description

It was reported that during a surgical procedure, it was observed that the array clamp device while being used with an array device and a fixation pin, moved when the surgeon's forearm bumped the array.It was reported that the system was unable to recognize the array device at this point and so the decision was made to switch to manual.It was reported that there was no patient harm and the surgery was completed successfully.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

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: 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: VELYS ARRAY CLAMP
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND UC; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthpaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 13357699
• MDR Text Key: 284450857
• Report Number: 1818910-2022-01637
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519379
• UDI-Public: 10603295519379
• Combination Product (y/n): N
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2022
• 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