MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE BAL BLK HANDLE; HANDLES

Model Number 2545-05-512

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

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

Attune balancing blocks (b)(4) missing handles.The handles were missing off the tray and were required for the procedure.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.  .

• Brand Name: ATTUNE BAL BLK HANDLE
• Type of Device: HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10119128
• MDR Text Key: 194017518
• Report Number: 1818910-2020-13207
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295481775
• UDI-Public: 10603295481775
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-05-512
• Device Catalogue Number: 254505512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1