MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH CT PIN GUIDE KIT L; KNEE ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number	420578
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
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.H11 additional narrative: 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 that the cartilage model predicted 2mm of cartilage on the medial plateau of the proximal tibia.The sales rep stated that the medial foot of the pin guide was airballing and the patient had no cartilage remaining on medial side.They discovered a good home for the guide despite medial foot not contacting.The down rod was running into the leg when checking alignment.After pinning, the cutting block was placed and down rod was checked again, the slope and alignment appeared correct.They made the cut and slope appeared correct but was still tight in flexion, therefor the recut and released pcl to open flexion gap.It was stated that the feet of the guide are supposed to contact the plateaus of the proximal tibia.The procedure was successfully completed and all available information has been disclosed for reporting.No further information was provided.
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.Found good home for the guide despite medial foot not contacting.Down rod was running into leg when checking alignment.After pinning the cutting block was placed and down rod was checked again, slope and alignment appeared correct.They made the cut and slope appeared correct but was still tight in flexion.Recut and released pcl to open flexion gap.It was stated that the feet of the guide are supposed to contact the plateaus of the proximal tibia".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 description: trumatch ct pin guide kit l product code: 420578 lot number: tmk00112748 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed for the 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 description: trumatch ct pin guide kit l product code: 420578 lot number: tmk00112748 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the 00112748 lot number and no non-conformances or manufacturing irregularities were identified.

• Brand Name: TRUMATCH CT PIN GUIDE KIT L
• Common Device Name: KNEE ARTHROPLASTY IMPLANTATION SYSTEM
• 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: 21503669
• Report Number: 1818910-2025-03276
• Device Sequence Number: 11909824
• Product Code: OOG
• UDI-Device Identifier: 10603295430797
• UDI-Public: (01)10603295430797(10)00112748
• 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

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: 00112748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female