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

Catalog 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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The posterior resections appeared so be significantly smaller than what the trumatch plan called for, about 4-5mm smaller on each side.The surgeon double checked rotation with a traditional sizer but then proceeded to use the trumatch placed distal pins for rotation and resection.They used the sized implants that trumatch planned for and the case had good results in the end, though the posterior resections were much different than the plan had originally called for.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.Device history lot
=
> 18538.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Type of Device: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8880353
• MDR Text Key: 153878010
• Report Number: 1818910-2019-100673
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420916
• Device Lot Number: 18538
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1