MAUDE Adverse Event Report: DEPUY ATTUNE FB IMPACTOR

Catalog Number D259807440 CR

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

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

Event Date 01/06/2016

Event Type  malfunction  

Event Description

The piece of depuy attune fb impactor broke off inside the prosthesis while positioning the prosthesis in place and unable to remove from pt.Depuy attune fb impactor tip broke off during placement of the corail prosthesis, during an anterior approach total hip replacement.It was unable to be removed from inside the prosthesis.Broken instrument removed from inside the prosthesis.Broken instrument removed from sterile field and sequestered.

• Brand Name: ATTUNE FB IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5778296
• MDR Text Key: 49147231
• Report Number: MW5063289
• Device Sequence Number: 1
• Product Code: LXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2016

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: D259807440 CR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 36