MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE FB PS ARTIC SURF SZ8; KNEE INSTRUMENT/TRIAL

Catalog Number 254500508

Device Problems Disassembly (1168); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

During the inspection of the attune returned loan kit, the orthokit technician noted that one spring is missing on the attune articulating surface.

• Brand Name: ATTUNE FB PS ARTIC SURF SZ8
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5188899
• MDR Text Key: 29872320
• Report Number: 1818910-2015-34061
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/26/2015

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 Catalogue Number: 254500508
• Device Lot Number: MVMBTN630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2014
• 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