MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB CUT BLCK MOUNT; RESECTION BLOCKS/DEVICES

Catalog Number 250610110

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the mount will not lock into place.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint sample consisted of (1) 250610110 attune rev tib cut blck mount, lot ab4206501.Examination of the returned device confirms the attune rev tib cut blck mount will not hold the attune revision tibial block r.The locking mechanism will not tighten onto the cutting block making it unable to hold the cutting block into place.A worldwide complaints database search was performed and found one other complaint ((b)(4)) where the attune rev tib cut blck mount would not hold the tibial cutting block.The root cause is determined to be undetermined.Due to the determination of the root cause no corrective action is being initiated but the complaints will be monitored through (b)(4).Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).

Event Description

It was reported that the attune rev tib cut blck mount does not tighten onto attune rev tibial block r.

• Brand Name: ATTUNE REV TIB CUT BLCK MOUNT
• Type of Device: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8437248
• MDR Text Key: 139354792
• Report Number: 1818910-2019-87898
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295436171
• UDI-Public: 10603295436171
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 250610110
• Device Lot Number: AB4206501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1