MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIBIAL TRIAL EXTRACTOR; EXTRACTION INSTRUMENTS

Catalog Number	254500138
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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 during the trialing phase, dr.Was attempting to remove the trial insert using the trial extractor.One side of the trial extractor tuning fork broke off.There was no delay.And all the broken parts were removed from the patient.
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).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: h6 medical device problem code.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received states that the one of the tips of the product cracked and broke off, the other side chipped off and that small chip was recovered from patient, but was lost in the washer sterilizer.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: it was reported that during the trailing phase, dr.Was attempting to remove the trial insert using the trial extractor.One side of the trial extractor tuning fork broke off.There was no delay.And all the broken parts were removed from the patient.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the attune tibial trial extractor has both of the prongs broken.Not all the broken fragments were returned for evaluation.Potential cause can be attributed to unintended use error, specifically the application of excessive force in a prying motion and material overload during use.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune tibial trial extractor 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.Added: b5.Corrected: h3.

• Brand Name: ATTUNE TIBIAL TRIAL EXTRACTOR
• Common Device Name: EXTRACTION 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: 23743591
• Report Number: 1818910-2025-21371
• Device Sequence Number: 12947810
• Product Code: HWB
• UDI-Device Identifier: 10603295131021
• UDI-Public: (01)10603295131021(10)BFA224A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2025

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: 254500138
• Device Lot Number: BFA224A
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 12/12/2025; 12/19/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/12/2025; 12/15/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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