MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MES SIZING/ROT GDE; ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS

Model Number 2544-00-525

Device Problem Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 11/26/2020

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

The primary surgery was performed on (b)(6) 2020 via tka.During the surgery, when the surgeon set the attune sizing rot guide, the device shifted to the right external rotation without holding a knob for rotation adjustment.There was a risk which the device was set over rotation, although, the device had interfered the patella.The surgery was completed within 30 minutes delay.The surgeon commented that he felt the stopper was working, but the device shifted.Because he might not be able to set the device to planned position, he wants the device stop at the set position.After the surgery, the sales rep checked the device, the device shifted to the right external rotation without holding a knob for rotation adjustment, and he found that the same event occurred with other lot of the device.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination.Visual examination of the provided video and photograph confirmed the reported event.No evidence was found indicating product error was a contributing factor.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot :the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE MES SIZING/ROT GDE
• Type of Device: ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11012296
• MDR Text Key: 223620627
• Report Number: 1818910-2020-26979
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295434061
• UDI-Public: 10603295434061
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-00-525
• Device Catalogue Number: 254400525
• Device Lot Number: AB4536235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1