MAUDE Adverse Event Report: DEPUY IRELAND TRUMATCH CT PIN GUIDE KIT R; PIN GUIDES

Catalog Number	420579
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported the pin guide was not able to be used due to the tibial slope being greater than 10 degrees during a total knee replacement.A conventional attune instrumentation was used to successfully complete the procedure with a 15 minute delay and no patient consequences.
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.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
Additional information was received and stated that the lack of accuracy of the pin guide due to the posterior slope over 10.Event occurred during intra-op.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "pin guide impossible to use due to a verified tibial slope greater than 10°." the product was returned to j&j medtech orthopaedics design team for evaluation.A 3d bone model and the tibia pin guide were reviewed for this investigation.Investigation revealed a correct fit of the trumatch ct pin guide kit r with the bone model.Therefore, the overall complaint cannot be confirmed.A product development investigation was performed and it was concluded that the segmentation is designed within trumatch specifications and no issues were identified.A manufacturing record evaluation was performed for the finished device product description: trumatch ct pin guide kit r product code: 420579 lot number: tmk00107623 and no non-conformances or manufacturing irregularities were identified.The overall complaint was unconfirmed as the observed condition of the trumatch ct pin guide kit r would not 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 j&j 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 : a manufacturing record evaluation was performed for the finished device product description: trumatch ct pin guide kit r product code: 420579 lot number: tmk00107623 and no non-conformances or manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device product description: trumatch ct pin guide kit r product code: 420579 lot number: tmk00107623 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: TRUMATCH CT PIN GUIDE KIT R
• Common Device Name: PIN GUIDES
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21941707
• Report Number: 1818910-2025-06789
• Device Sequence Number: 12898547
• Product Code: OOG
• UDI-Device Identifier: 10603295430803
• UDI-Public: (01)10603295430803(17)250630(10)00107623
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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 Expiration Date: 06/30/2025
• Device Catalogue Number: 420579
• Device Lot Number: 00107623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 06/04/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/06/2025; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown