MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER ELBOW SET; IMPLANT

Model Number 00-4901-020-15

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/24/2018

Event Type  malfunction  

Event Description

During an open reduction internal fixation of the patients left humerus, a 2.0mm k wire that was in the humerus broke.The surgeon left the broken piece in the bone, as he felt would cause more damage than good to try and remove it.

• Brand Name: ZIMMER ELBOW SET
• Type of Device: IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET; 345 e main st; warsaw IN 46580
• MDR Report Key: 7788343
• MDR Text Key: 117292067
• Report Number: 7788343
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/13/2018,08/07/2018

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 Model Number: 00-4901-020-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2018
• Date Report to Manufacturer: 08/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6570 DA