MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PRIMARY RESECTIONS; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Model Number 2545-01-701

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

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.

Event Description

It was reported that there was no harm or delay.Attune total knee instrument trays were beginning to delaminate on the inside.The black pieces that hold instruments in place were starting to peel back.The hospital was concerned that this could create a possibility for harboring bacteria.So they requested that we replace the trays.

• Brand Name: ATTUNE PRIMARY RESECTIONS
• Type of Device: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• 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: 10472411
• MDR Text Key: 207731517
• Report Number: 1818910-2020-19091
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295423515
• UDI-Public: 10603295423515
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2020

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: 2545-01-701
• Device Catalogue Number: 254501701
• Device Lot Number: PV0034286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2013
• 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