MAUDE Adverse Event Report: DEPUY IRELAND 9616671 TRUMATCH ATTUNE KIT LEFT; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number 420945

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.

Event Description

It was reported that the surgeon used a different size tibia than the trumatch plan suggested.A size three (3) tibia was used instead of a size two (2).The resection level was not adjusted and did match the plan.

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.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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : 098kh.Device history batch : null.Device history review : dhr reviewed no deviations or nonconformances were noted.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 ATTUNE KIT LEFT
• Type of Device: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8350144
• MDR Text Key: 136614966
• Report Number: 1818910-2019-85039
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295431794
• UDI-Public: 10603295431794
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420945
• Device Lot Number: 098KH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1