MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE 0 DEG LEFT CUT BLOCK; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number 2544-00-014

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

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

It was reported that the holes of the block that connect to the jig are warped or pinched.The block gets stuck on the tibia jigs.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE 0 DEG LEFT CUT BLOCK
• Type of Device: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10271079
• MDR Text Key: 198720922
• Report Number: 1818910-2020-15781
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295421078
• UDI-Public: 10603295421078
• 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
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-00-014
• Device Catalogue Number: 254400014
• Device Lot Number: PG225456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1