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

Catalog Number 420915

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the metal cutting slot on the femoral trumatch guide has been backing out as it was cut through it.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that the metal cutting slot on the femoral trumatch guide has been backing out as it was cut through it.It has never happened before, but happened during the past 2 cases.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 l product code: 420915 lot number: tmk00065108 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed for trumatch ct cut guide kit l.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 l product code: 420915 lot number: tmk00065108 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: tmk00065108 and no non-conformances or manufacturing irregularities were identified.

• 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: 18547661
• MDR Text Key: 333287205
• Report Number: 1818910-2024-01468
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420915
• Device Lot Number: 00065108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• 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