MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN REV LPS INS BASE TRL ADPT; TIBIAL TRIALS

Catalog Number	251760002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal shaving on the attune revision lumbar puncture shunt "lps" insert base trial adapter broke off.
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.The expiration date (12/31/2099) in the initial medwatch was reported in error.The device involved was an instrument and does not have an expiration date.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: it was reported that the metal shaving on the attune revision lps insert base trial adapter broke off.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found one prong bent.Device had signs of usage and no other anomaly was identified on its surface.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces during the assembling or disassembling process.Properly handling and attention to the approved use of the device diminishes the risk of failure.Although no breakage was observed, the reported allegation is confirmed, as excessive loading could cause damage beyond the noted deformation and potentially lead to device breakage.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the atun rev lps ins base trl adpt 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.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, it was reported that the metal shaving on the attune revision lps insert base trial adapter broke off.The product was not returned to depuy synthes; however photos were provided for review.Photos were provided for review; however the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.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.Added: e3.Corrected: e2.

• Brand Name: ATUN REV LPS INS BASE TRL ADPT
• Common Device Name: 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: 24027595
• Report Number: 1818910-2026-00495
• Device Sequence Number: 10545903
• Product Code: HWT
• UDI-Device Identifier: 10603295480174
• UDI-Public: (01)10603295480174(10)MI84232
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2026

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: 251760002
• Device Lot Number: MI84232
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 01/21/2026; 02/17/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/13/2026; 01/22/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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 Age: 53 YR
• Patient Sex: Male