MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254401014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery with the attune system and when using the attune knee test inserts, it was detected that one of the springs fell off and remained inside the knee.It could be removed without leaving any remains on the patient.However, this fact is a very serious situation, since it compromises the intraoperative safety and the reliability of the instruments.It also generates insecurity regarding the size of the test insert and can modify the height of the liners altering the reliability of the instrument and thus open a wrong definitive implant.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional 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 that 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 recon described in this report.H11 additional narrative: added: d4 lot, h4.Corrected: d1, d2a, d4 (catalog, primary udi number).If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received " when using the attune knee test inserts, detected that one of the springs fell off and remained inside the knee.At the time and he himself could be removed without leaving any remains on the patient.¿ the product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that the attune spacer block had a missing spring.The observed condition of the device was consistent with use of excessive force in a prying motion while trialing.Properly handling and attention to the approved use of the device diminishes the risk for this type of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune spacer block would contribute to the complained device issue.Based on the investigation findings, it has been determined that 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: 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: ATTUNE SPACER BLOCK
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23190706
• Report Number: 1818910-2025-16860
• Device Sequence Number: 10074930
• Product Code: HWT
• UDI-Device Identifier: 10603295133438
• UDI-Public: (01)10603295133438(10)BFA1P6Y
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 254401014
• Device Lot Number: BFA1P6Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 03/02/2026
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 12/19/2025; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2021
• 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