MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS ARRAY SET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the system feels loose.When attempted a second pass on the distal femur cut, the incision was 3mm off.They used additional cement on the medial condyle side so there was no negative patient impact.They are requesting to have the unit serviced due to the loose feeling.They noticed that the tibial array popped out of the clamp during the procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information provided, "the doctor states that the system feels loose.When he went back to do a second pass on the distal femur cut, the incision was 3mm off.They used additional cement on the medial condyle side so there was no negative patient impact.They are requesting to have the unit serviced due to the loose feeling.Troubleshooting: they noticed that the tibial array popped out of the clamp during the procedure" the array set was not returned, however the investigation performed under (b)(4) involving the base station, confirmed there was evidence of array movement.During the tibial cut, there was evidence of tibial array movement.This suggests that the unclamping of the tibial array as described in the complaint likely caused array movement during the tibial cut.The investigation found that there is insufficient evidence to determine what lead to the array movement.It is possible the array may have moved due to not being clamped down correctly, but a review of the log files cannot determine what triggered the array to move.Based on the investigation findings, no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device h11 additional narrative: added: b5.
Event or Problem Description
Additional information received states that the reporter stated that "the arm and possibly the array captures.".

• Brand Name: VELYS ARRAY SET
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; 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: 20038530
• Report Number: 1818910-2024-17850
• Device Sequence Number: 17769297
• Product Code: OLO
• UDI-Device Identifier: 10603295519072
• UDI-Public: (01)10603295519072
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K202769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 451570001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown