MAUDE Adverse Event Report: ZIMMER INC 1.8 PARTIALLY THREADED K-WIRE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2020

Event Type  malfunction  

Event Description

1.8 mm k-wire tip broke in operative bone site, was not able to be retrieved.

• Brand Name: 1.8 PARTIALLY THREADED K-WIRE
• Type of Device: WIRE
• Manufacturer (Section D): ZIMMER INC; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 10860120
• MDR Text Key: 216919795
• Report Number: 10860120
• Device Sequence Number: 1
• Product Code: LRN
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other