MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 VELYS ARRAY SET KNEE; ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY

Model Number 4515-70-011

Device Problem Unintended Movement (3026)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).Email received on 21-oct-2022 from reporter with additional event information.The reporter stated that "surgeon was able to pull out the tibia array from the clamp.I had the sales consultant after the surgery was done replicate the same event with 2 different array clamps.The outcome from this field test was successful.The concern is the tibia array in this lot family.The sales consultant will be sending back the array for inspection.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the array clamp came loose from the tibia array during surgery.When was the issue observed: during surgery.Troubleshooting: tested connection with other clamps following surgery and they came loose with same tibia array.Patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? no.Are patient treatments delayed or cancelled? no.Next day of surgery: unknown.What date and time (approx.) did the error or complaint take place:(b)(6) 2022.All information has been disclosed.No further information was provided.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> the device associated with this report was returned to depuy synthes for evaluation.Functional testing of the returned tibial array component with production equivalent velys array clamps was successful.The tibial array fully assemble and disassembled with the array clamp as intended.The event described could not be replicated, therefore the reported condition could not be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot
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> 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.H3.

Manufacturer Narrative

Product complaint #(b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VELYS ARRAY SET KNEE
• Type of Device: ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15742819
• MDR Text Key: 307081141
• Report Number: 1818910-2022-22182
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: 10603295520146
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4515-70-011
• Device Catalogue Number: 451570011
• Device Lot Number: MK218263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1