MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE DISTAL FEM CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number 254400522

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

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

It was reported that the disposable pin (p/n: 254400111) was caught and stopped in the distal femur cut block (p/n: 254400522) and broken when the surgeon inserted the disposable pin with the reamer through the distal femur cut block for cutting the distal end of femur during the tka surgery on (b)(6) 2019. The surgery was completed and there was no adverse consequence to the patient. There were no broken parts in the patient¿s body. No further information is available.

• Brand Name: ATTUNE DISTAL FEM CUT BLOCK
• Type of Device: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8358431
• MDR Text Key: 136766618
• Report Number: 1818910-2019-85395
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 254400522
• Device Lot Number: ABC29330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown