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

Catalog Number	420916
Medical Device Problem Codes	Incorrect Measurement (1383); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tibial cut was in 10 or 12 degrees (varus angle).The trumatch case was planned at perpendicular to mechanical axis.Noted the case was perfect psa alignment.No adverse outcome for patient.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided, ¿tibial cut was in 10 or 12 degrees (varus angle).The trumatch case was planned at perpendicular to mechanical axis.Noted the case was perfect psa alignment.No adverse outcome for patient.Trumatch case: (b)(4).¿ the product was not returned to depuy synthes, however an x-ray image was provided for review.See attachment (post op xray_frasier.Jpg).A screenshot of an x-ray was provided showing a postop right tka.The x-ray shows an overcut on the internal tibial aspect (or overcut on the external side) that makes the tibial tray deviate into a varus position, however, without additional evidence the actual postop knee aliment axis is unknown.Based on the voice of the customer, the reported varus tibial tray position is confirmed.A product development investigation was performed and it was concluded that the segmentation, design proposal (plan), and guide design were all designed within trumatch specifications.No issues were identified that would have contributed to the varus tibial positioning.A manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit r product code: 420916 lot number: 56846 and no non-conformances or manufacturing irregularities were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint revealed there was no malfunction with the trumatch ct cut guide kit r, but rather the either surgical technique or patient anatomy contributed to the confirmed varus tray position.Based on the investigation findings, it is suspected that surgical technique and customer dissatisfaction with the design plan contributed to the varus position of the tibial tray, however a definitive cause could not be determined.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 record evaluation was performed for the finished device product description: trumatch ct cut guide kit r product code: 420916 lot number: 56846 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Common Device Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17885518
• Report Number: 1818910-2023-20391
• Device Sequence Number: 17964216
• Product Code: OOG
• UDI-Device Identifier: 10603295384861
• UDI-Public: 10603295384861
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 420916
• Device Lot Number: 00056846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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