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

Catalog Number 254400520

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

The silver ring inside the hole on the attune distal femoral jig gets pushed out or comes out when the pin is taken out.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this 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.

Manufacturer Narrative

The complaint states the silver ring inside the hole on the attune distal femoral jig gets pushed out or comes out when the pin is taken out.The bushings were assembled to the device in the correct orientation and one of the bushings on the returned device had come out and was returned.(b)(4) is currently underway to investigate this issue.The complaint shall be closed to capa and entered into the complaints database and monitored through trend analysis.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

The complaint states the silver ring inside the hole on the attune distal femoral jig gets pushed out or comes out when the pin is taken out.The bushings were assembled to the device in the correct orientation and one of the bushings on the returned device had come out and was returned.Capa-(b)(4) is currently underway to investigate this issue.The complaint shall be closed to capa and entered into the complaints database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 4620658
• MDR Text Key: 18291678
• Report Number: 1818910-2015-16720
• 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,distributor,health prof
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• 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: ABD19369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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: 69 YR