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

Model Number 2544-00-522

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

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 cutting block won't securely attach to distal fem jig.No surgical delay.

Manufacturer Narrative

Product complaint (b)(4).

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.Product complaint # : (b)(4).Investigation summary: examination and functional evaluation of the returned device could not replicate the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.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, a follow-up medwatch will be filed as appropriate.

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.Product complaint # (b)(4).Investigation summary examination and functional evaluation of the returned device could not replicate the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.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.Device history lot null device history batch null device history review null 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 DISTAL FEM CUT BLOCK
• Type of Device: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9860541
• MDR Text Key: 190361520
• Report Number: 1818910-2020-08752
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295423737
• UDI-Public: 10603295423737
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2020

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: 2544-00-522
• Device Catalogue Number: 254400522
• Device Lot Number: ABC35355
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/02/2020; 04/08/2020; 04/08/2020
• Supplement Dates FDA Received: 03/31/2020; 04/08/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1