MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE NOTCH GUIDE SZ 3; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number 2545-00-023

Device Problem Incorrect Measurement (1383)

Patient Problems Bone Fracture(s) (1870); Not Applicable (3189)

Event Date 12/02/2019

Event Type  Injury  

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 since the accuracy of the notch guide (p/n: 254500023) was low, some bone was left at the time of osteotomy of intercondylar of the femur during the tka surgery on (b)(6) 2019 for the patient's right knee joint, after that the femur fracture occurred when inserting a femoral component trial.It was fixed with 2 screws and the surgery was completed within a 30 minutes surgical delay.It was requested from the surgeon that improvement of the notch guide.No further information is available.

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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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).Examination of the returned device could not confirm the reported event.Depuy considers the investigation closed.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 NOTCH GUIDE SZ 3
• Type of Device: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9501720
• MDR Text Key: 173973548
• Report Number: 1818910-2019-124315
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295130406
• UDI-Public: 10603295130406
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-023
• Device Catalogue Number: 254500023
• Device Lot Number: PG235517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 02/27/2020
• Supplement Dates FDA Received: 01/28/2020; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1