MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ3; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-503

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

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.

Event Description

It was reported that the tka surgery was performed on (b)(6) 2019 by using the tibial insert trial (p/n: 254500973).The surgery was completed smoothly.Since the tibial insert trial did not come out from the knee joint separately, it was not checked the ring part of the tibial insert trial.The sales rep obtained the information from the doctor on nov 1st, 2019 that there was something like a spring on x-ray.The sales rep confirmed the x-ray that there was a high possibility of spring of the insert trial came off and had been remaining in the patient's the lateral tibial posterior.No further information is available.

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.H10 additional narrative: product complaint (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: ATTUNE FB PS ARTIC SURF SZ3
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9384184
• MDR Text Key: 187626446
• Report Number: 1818910-2019-118410
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295132431
• UDI-Public: 10603295132431
• 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
• Report Date: 11/01/2019

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: 2545-00-503
• Device Catalogue Number: 254500503
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1