MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DISTAL FEMORAL JIG; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number 254400521

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

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.

Event Description

Der states that during distal femoral resection the surgeon thought that the cut was bigger than he planned.We decided to replace the instrument because it is unknown to us if the extra resection was due to an inaccurate guide or if it was possibly set up incorrectly.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE DISTAL FEMORAL JIG
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7137449
• MDR Text Key: 95474230
• Report Number: 1818910-2017-52268
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 254400521
• Device Lot Number: ABB72107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Date Device Manufactured: 01/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR