MAUDE Adverse Event Report: DEPUY IRELAND VELYS ARRAY CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570107
Medical Device Problem Codes	Device Slipped (1584); Device-Device Incompatibility (2919); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional 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, 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.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during set-up for a total knee arthroplasty (tka) surgical procedure it was observed that 3x robotic assisted array clamp devices were coming loose on their own.There were no adverse consequences to the patient.No additional information could be provided.This is report 3 of 3 for (b)(4).
Additional 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, 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.H11 additional narrative: h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.
Additional Manufacturer Narrative
Clinician reply 03-11-2026: downgrading of coding is appropriate based upon review by (b)(4): since (b)(4) were reported for separate events involving the same array clamps, the additional event information, shared on (b)(4) via the follow-up response (re: third velys product complaint follow-up (b)(4)), also pertains to (b)(4).Per the aei, there were two array clamp assemblies (not three) and the arrays had come loose from the array clamps.Therefore, the following actions need to be taken: 1.(b)(4) needs to be updated to a velys array set knee (p/n 451570011, lot unk).2.(b)(4) needs to be updated with both lot numbers pc5939720 and pc5954777 in the unrecognized field.3.The array set and array clamp ips must be coded with device interaction (2+ devices): unintended/unexpected disengagement.

• Brand Name: VELYS ARRAY CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24376689
• Report Number: 1818910-2026-03195
• Device Sequence Number: 4862663
• Product Code: OLO
• UDI-Device Identifier: 10603295519379
• UDI-Public: (01)10603295519379(10)PC5954777
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 451570107
• Device Lot Number: PC5954777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/06/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/19/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown