MAUDE Adverse Event Report: DEPUY DEPUY ATTUNE ROTATING PLATFORM TIBIAL IMPACTOR

Device Problem Break (1069)

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

Event Date 06/10/2015

Event Type  malfunction  

Event Description

Piece of handle of the depuy pinnacle impactor broken off while in use during a right total hip replacement.Piece retrieved and instrument sequestered.As surgeon was using the depuy pinnacle cull impactor during a right total hip replacement, the small piece of the handle broke off.It was retrieved and instrument was removed from sterile field and sequestered.

• Brand Name: DEPUY ATTUNE ROTATING PLATFORM TIBIAL IMPACTOR
• Type of Device: DEPUY ATTUNE ROTATING PLATFORM TIBIAL IMPACTOR
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5454954
• MDR Text Key: 38975969
• Report Number: MW5060413
• 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
• Type of Report: Initial
• Report Date: 02/17/2016

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
• Other Device ID Number: AU3702674, D254401004
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 87