MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE DISTAL FEMORAL JIG; KNEE INSTRUMENT/TRIAL

Catalog Number 254400520

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Examination of the returned device confirms the reported event of bushing migration.The trend of complaints related to the disassociation of a number of these bushings, in correctly manufactured parts, has led to the initiation of corrective and preventative action.The root cause is attributed to product design.(b)(4) is currently underway to investigate this issue.Post market surveillance is per (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Originally submitted on (b)(6) 2016, but did not pass all three acknowledgements, resubmitting due to fda request.

Event Description

The attune femoral jig has a loose drill bushing.

• Brand Name: ATTUNE DISTAL FEMORAL JIG
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581
• MDR Report Key: 6177015
• MDR Text Key: 62467568
• Report Number: 1818910-2016-33216
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2016

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: 254400520
• Device Lot Number: ABD56125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• 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: 57 YR