MAUDE Adverse Event Report: ZIMMER BIOMET BIOMET- HIP TRAY; IMPACTOR

Model Number 423598

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/29/2018

Event Type  Injury  

Event Description

Instrument (impactor) broke while in use on pt.The composite material "splintered" into couple of pieces.All pieces retrieved.

• Brand Name: BIOMET- HIP TRAY
• Type of Device: IMPACTOR
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 8064700
• MDR Text Key: 127071842
• Report Number: MW5081173
• Device Sequence Number: 0
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 423598
• Device Catalogue Number: 368490
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR