MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC ATTUNE DISTAL FEMORAL JIG; KNEE INSTRUMENT/TRIAL

Catalog Number 254400520

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

One of the metal pin bushings came out of the attune femoral jig.

Manufacturer Narrative

Incident did not occur outside the (b)(6) and is not reportable to the competent authorities.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The complaint states one of the metal pin bushings came out of the attune femoral jig.Root cause: manufacture the bushings were assembled to the device in the incorrect orientation and thus the device does not conform to the drawing specification.(b)(4) is currently underway to address this issue.No design defect was identified on this part.It should be noted that a field safety notice was issued in oct 2014 stating for theatre staff and persons involved with the cleaning and reprocessing of the device are requested to inspect all inventory for specific lots (stated in the fsn).In the instance that a device is found to be assembled incorrectly it has been requested to be returned and exchanged for a correctly assembled device.The device is from a an affected lot.The complaint shall.

• Brand Name: ATTUNE DISTAL FEMORAL JIG
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4272003
• MDR Text Key: 5007032
• Report Number: 1818910-2014-32349
• Device Sequence Number: 1
• Product Code: LXH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254400520
• Device Lot Number: ABC60842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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
• Patient Age: 62 YR