MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT TRL35MM; ATTUNE INSTRUMENTS : PATELLA TRIALS

Catalog Number	254501027
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 (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 35 dome patella button was chipped.It was further reported that the device was cracked.According to the reporter, part of the plastic was worn away from the top of the patella button making the surface no longer smooth; a chunk was missing.All available information has been disclosed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information provided: "it was reported that 35 dome patella button was chipped", "it was cracked.There was a big chunk out of the plastic missing" and "chipped as in there was a significant amount of plastic worn away from the top of the patella button making the surface no longer smooth.A chunk was missing".The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found deep scratches and a chipped portion on its convex surface.Device had signs of heavy usage and no other anomaly was identified.Potential cause for both scratches and chipped patterns observed can be traced to unintended use error conditions, as the scratches can be consistent with other tools and hard edges coming in contact with the device; and the chipped patterns can be consistent with exposure to unintended forces like usage of excessive force in a prying motion while trialing.However, taking in consideration the aspect and age of the device (around 12 years), the observed condition was identified as an end of life indicator; damage 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.Given the evidence provided, the reported allegation can be confirmed as a crack propagation can lead to the chipped patterns observed.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune medial dome pat trl35mm would have contributed 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 reported 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.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE MEDIAL DOME PAT TRL35MM
• Common Device Name: ATTUNE INSTRUMENTS : PATELLA 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: 23476157
• Report Number: 1818910-2025-19135
• Device Sequence Number: 16060072
• Product Code: HWT
• UDI-Device Identifier: 10603295136040
• UDI-Public: (01)10603295136040(11)130306(10)MVMBHW760
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: 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: 254501027
• Device Lot Number: MVMBHW760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2013
• 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