MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 TRUMATCH CT CUT GUIDE KIT R; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	420916
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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.
Event or Problem Description
Proceeded to secure the trumatch jig with osteophytes still intact.Outcome was femoral rotation was internally rotated.Coronal alignment is good but had to recut distal femur to +4mm.Also, had downsize femur to size 7 instead of 8.Proximal tibial needed to recut +2mm.
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 that 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, health effect (clinical code & impact code.
Event or Problem Description
2.Was there a surgical delay? if yes, what is the duration of the delay? recut of distal femur and proximal tibial added at least 15 minutes as normal.3.Was there any adverse consequences that affected the patient because of the reported event? post-op report from operating surgeon: femur appears flexed on post-op x-ray and tibia on slight valgus.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : we proceeded to sue the trumatch jig with osteophytes still intact.Outcome was femoral rotation was internally rotated.Coronal alignment is good but had to recut distal femur to +4mm.Also, had downsize femur to size 7 instead of 8.Proximal tibial needed to recut +2mm.The device associated with this report was not returned to depuy synthes 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 cut guide kit r product code: 420916 lot number: tmk00073224 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed for trumatch ct cut guide kit r 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 record evaluation was performed for the finished device product description: trumatch ct cut guide kit r product code: 420916 lot number: tmk00073224 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 IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 18911932
• Report Number: 1818910-2024-05782
• Device Sequence Number: 7042868
• Product Code: OOG
• UDI-Device Identifier: 10603295384861
• UDI-Public: 10603295384861
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

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: 00073224
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 04/25/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/03/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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 Sex: Unknown