MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH CT CUT GUIDE KIT L; RESECTION BLOCKS/DEVICES

Catalog Number	420915
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a problem with the trumatch today for the first time.During insertion, the distal femur guide was difficult to fully apply.The planning gave a size 6 femur, but surgeon used a femoral sizer from the ancillary because the rotation given seemed completely incorrect, as did the sizing.Agreed on a size 4 for the femur.This is still a big difference from size 6.For the tibia, surgeon also had to switch to a size 4 instead of the 5 planned in the planning.Surgeon didn't make any large cuts and had to re-cut the distal femur because the extension space was too tight.
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.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "noticed a problem with the trumatch (b)(4), today for the first time.During insertion, the distal femur guide was difficult to fully apply.The planning gave a size 6 femur, but we used a femoral sizer from the ancillary because the rotation given seemed completely incorrect, as did the sizing.We agreed on a size 4 for the femur.This is still a big difference from size 6.For the tibia, we also had to switch to a size 4 instead of the 5 planned in the planning.We didn't make any large cuts and had to re-cut the distal femur because the extension space was too tight.Is it possible that this was due to a scanner error?" the device associated with this report was not returned to medtech orthopaedics for evaluation.However, photos were provided for review.See attachment [picture 1,2,3].The photo investigation revealed that the provided photo does not represent the reported device.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 cut guide kit l product code: 420915 lot number: (b)(6) and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed for trumatch ct cut guide kit l would have not 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 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 cut guide kit l product code: 420915 lot number: (b)(6) 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 cut guide kit l product code: 420915 lot number: (b)(4) and no non-conformances or manufacturing irregularities were identified.

• Brand Name: TRUMATCH CT CUT GUIDE KIT L
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22157384
• Report Number: 1818910-2025-09194
• Device Sequence Number: 18312412
• Product Code: NJL
• UDI-Device Identifier: 10603295384854
• UDI-Public: (01)10603295384854(17)250930(10)00121777
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Expiration Date: 09/30/2025
• Device Catalogue Number: 420915
• Device Lot Number: 00121777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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 Sex: Unknown