MAUDE Adverse Event Report: DEPUY ATTUNE FEMORAL IMPACTION HANDLE

Catalog Number 0254401017

Device Problem Break (1069)

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

Event Date 04/18/2016

Event Type  malfunction  

Event Description

Reusable loaner instrumentation broke during total knee replacement surgery.During total knee replacement, surgeon was utilizing the depuy attune femoral impaction handle and the red coated tip piece and spring broke off.All pieces recovered from wound and sequestered.

• Brand Name: ATTUNE FEMORAL IMPACTION HANDLE
• Type of Device: ATTUNE FEMORAL IMPACTION HANDLE
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5603380
• MDR Text Key: 43775794
• Report Number: MW5061850
• Device Sequence Number: 1
• Product Code: JWH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2016

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: 0254401017
• Device Lot Number: NW147391
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 96