MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE BALANCED FEMORAL SIZER; SIZING/MEASURING INSTRUMENTS

Catalog Number	254400517
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Attune balancing sizer is faulty.The sizing guide is not sliding over the distractor.It is very tight and will not function properly to allow for sizing and balancing.There was no patient consequence.
Additional Manufacturer Narrative
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.
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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿attune balancing sizer is faulty.The sizing guide is not sliding over the distractor.It is very tight and will not function properly to allow for sizing and balancing¿.The attune balanced femoral sizer (lot.Abb58371) returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that the locking prongs of the distal section were found bent inward.Additionally, the device exhibits an overall worn condition consistent with normal and constant usage.Functional testing was performed with the returned mating instruments.The assessment revealed that the attune bal sizer distractor was not able to easily slide into the attune balanced femoral sizer (lot.Abb58371); most likely due to the observed deformation of the locking tabs.The observed condition of the prongs was consistent with a random component failure that may have been caused by exposure to unintended forces, such as, dropping, crushing or misuse.In some cases, the prongs are intentionally bent inward to remove the locking nut (component number (b)(6)) for cleaning purposes.This is not intended to happen; the device is designed to be cleaned with the nut in place.The overall complaint was confirmed as the observed condition of the attune balanced femoral sizer 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 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 BALANCED FEMORAL SIZER
• Common Device Name: SIZING/MEASURING INSTRUMENTS
• 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: 23403677
• Report Number: 1818910-2025-18442
• Device Sequence Number: 4916960
• Product Code: HWT
• UDI-Device Identifier: 10603295327554
• UDI-Public: (01)10603295327554(10)ABB58371
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: 254400517
• Device Lot Number: ABB58371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 12/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/19/2025; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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