MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MOD POST SAW CAP SZ 3-5; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	254500045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
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 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 red clip on the attune sz 3-5 posterior saw capture was depressed to allow connection to four in 1 block and broke off after normal use.The procedure being performed was arthroplasty.There was no patient involvement.All information that are known/available has been disclosed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "attune sz 3-5 posterior saw capture red clip that is depressed to allow connection to four in 1 block broke off after normal use." the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that '254500045, attune mod post saw cap sz 3-5¿ had broken.The breakage is consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.With the available data and understanding of the surgical process, no corrective and/or preventative action is recommended.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune mod post saw cap sz 3-5 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life and 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 medtech orthopaedics 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 MOD POST SAW CAP SZ 3-5
• Common Device Name: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• 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: 23526303
• Report Number: 1818910-2025-19587
• Device Sequence Number: 10202843
• Product Code: LXH
• UDI-Device Identifier: 10603295130529
• UDI-Public: (01)10603295130529(10)PG248392
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 254500045
• Device Lot Number: PG248392
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2015
• 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