MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIB PREP & IMPACT; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Model Number 2545-01-702

Device Problem Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

Event Description

It was reported that after total knee case with an attune instrument set, while the instruments were being cleaned by sterile processing dept, the spd staff noticed that there was some wear on the black inner components that the instruments sit in on two attune trays, the tibial prep & impaction and the femoral sizing & finishing trays.The staff asked that these trays be replaced because they were not confident that the current trays could be sterilized due to the wear.There was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was received for examination.Visual examination of the returned device found the device plastic coating on the metal posts inside is peeling.The reported condition was 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE TIB PREP & IMPACT
• Type of Device: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15614120
• MDR Text Key: 304532466
• Report Number: 1818910-2022-20502
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295423522
• UDI-Public: 10603295423522
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2022

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: 2545-01-702
• Device Catalogue Number: 254501702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male