MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH CT PIN GUIDE KIT L; PIN GUIDES

Catalog Number	420578
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
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 narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that patient underwent total knee replacement on (b)(6) 2025.Cartilage model predicted 2mm of cartilage on the medial plateau of the proximal tibia.Sales representative stated that the medial foot of the pin guide was air balling and the patient had no cartilage remaining on medial side.They ended up re-cutting the tibia by an additional 4mm and the femur by 2mm.Released pcl to open flexion gap and used 5mm tibia poly.Procedure was completed successfully.
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.H10 additional narrative: corrected: d4 (primary udi #).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: "cartilage model predicted 2mm of cartilage on the medial plateau of the proximal tibia.Rep stated that the medial foot of the pin guide was airballing and the patient had no cartilage remaining on medial side.The did end up re-cutting the tibia by an additional 4mm and the femur by 2mm.Released pcl to open flexion gap and used 5mm tibia poly".The device associated with this report was not returned to medtech orthopaedics for evaluation.The investigation could not confirm the reported event.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 code: 420578, product name: trumatch ct pin guide kit l, lot number: tmk00112413, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was not confirmed for trumatch ct pin guide kit l.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 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 code: 420578, product name: trumatch ct pin guide kit l, lot number: tmk00112413, and no non-conformances nor manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device tmk00112413 lot number, and no non-conformances nor manufacturing irregularities were identified.

• Brand Name: TRUMATCH CT PIN GUIDE KIT L
• Common Device Name: PIN GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21518309
• Report Number: 1818910-2025-03416
• Device Sequence Number: 12875537
• Product Code: OOG
• UDI-Device Identifier: 10603295430797
• UDI-Public: (01)10603295430797(10)00112413
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: 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: 420578
• Device Lot Number: 00112413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/06/2025; 03/27/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/11/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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 Age: 73 YR
• Patient Sex: Male