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

Model Number 420916

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.No evidence was found indicating product error was a contributing factor to the reported event.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

Event Description

Post op images seem to have put the tibial cuts into varus, as this seemed to be a consistent challenge.He wanted to give feedback.Wondered if could be any learnings as strange for all to be following same pattern and he feeds back that he felt the tibial guide fit was solid on each.

Manufacturer Narrative

Product complaint # (b)(4).Corrected d4 (expiration date): no expiration date to be reported.

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Type of Device: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9239371
• MDR Text Key: 165971004
• Report Number: 1818910-2019-112093
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295384861
• UDI-Public: 10603295384861
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 420916
• Device Catalogue Number: 420916
• Device Lot Number: 05242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1