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

Catalog Number 420915

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint(b)(4).B3: date of event is an unknown date.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.

Event Description

It was reported that the femoral rotation was off during a case.The trumatch femoral block was actually positioned in extreme internal rotation.A sizing guide was used to correct the issue.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: they did a case last week with surgeon and the femoral rotation was way off.The trumatch femoral block actually positioned us in extreme internal rotation.They recognized and aborted to a sizing guide to correct the issue.Can you please review the plan and see if anything can be identified on your end? the device associated with this report was not returned to depuy synthes for evaluation.A product development investigation was performed and it was noted that the femoral resection guide did not fit correctly on the patient bone.This issue is being addressed by depuy quality system.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 there were no manufacturing related non-conformances.The overall complaint was confirmed for trumatch ct cut guide kit l.Based on the investigation findings, the root cause is traced to design.The product issue has been addressed through depuy synthes quality system.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 l product code: 420915 lot number: (b)(6) and there were no manufacturing related non-conformances.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: they did a case last week with surgeon and the femoral rotation was way off.The trumatch femoral block actually positioned us in extreme internal rotation.They recognized and aborted to a sizing guide to correct the issue.Can you please review the plan and see if anything can be identified on your end? the device associated with this report was not returned to depuy synthes for evaluation.A product development investigation was performed and it was noted that the femoral resection guide did not fit correctly on the patient bone.This issue is being addressed by depuy quality system.A manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit l product code: 420915 lot number: tmk00069338 and there were no manufacturing related non-conformances.The overall complaint was confirmed for trumatch ct cut guide kit l.Based on the investigation findings, the root cause is traced to design.The product issue has been addressed through depuy synthes quality system.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 l product code: 420915 lot number: tmk00069338 and there were no manufacturing related non-conformances.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: tmk00069338 and there were no manufacturing related non-conformances.

• Brand Name: TRUMATCH CT CUT GUIDE KIT L
• Type of Device: 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 ; 3035526892
• MDR Report Key: 18562640
• MDR Text Key: 333460753
• Report Number: 1818910-2024-01576
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295384854
• UDI-Public: 10603295384854
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female