MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH 3.0 CT PT PLAN; TEMPLATES

Catalog Number	431001
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the medial side from memory stated 3mm ish cut and 9 from high.Because of tibial wear medial/posterior it was a 12mm cut to avoid air swing.We found this out intraoperatively but did say when he looked at plan it was not accurate and questioned where you took landmarks particularly on the medial side of tibia.
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 manufacturer narrative: a1: tmk00142295.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "the medial side from memory stated 3mm ish cut and 9 from high.Because of tibial wear medial/posterior it was a 12mm cut to avoid air swing.We found this out intraoperatively but did say when he looked at plan it was not accurate and questioned where you took landmarks particularly on the medial side of tibia" and "no actual guides were produced and used in the case due to time restrictions.I was referring only to the plan they provided the surgeon so things like delay and lot number aren¿t applicable.He was provided information prior to the case but didn¿t use it because it wasn¿t accurate".The device associated with this report was not returned to depuy synthes for evaluation.The investigation could not confirm the reported event due to insufficient evidence provided.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 records evaluation (mre) was not performed as no lot number was provided for this complaint.If the lot/serial number becomes available, the record will be re-assessed.The overall complaint was not confirmed for trumatch 3.0 ct pt plan.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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this complaint.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: d10.

• Brand Name: TRUMATCH 3.0 CT PT PLAN
• Common Device Name: TEMPLATES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23366235
• Report Number: 1818910-2025-18073
• Device Sequence Number: 15940153
• Product Code: HWT
• UDI-Device Identifier: 10603295451907
• UDI-Public: (01)10603295451907
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,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: 431001
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRUMATCH 3.0 CT PT PLAN
• Patient Sex: Unknown