MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX PILLING WECK RONGUER; RONGEUR

Catalog Number 386160

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

Surgeon was doing a right total knee on the patient with hardware removal.They were using a rongeur and the screw in the joint of the instrument fell out into the knee of the patient.The screw was found.The screw and rongeur were removed off the field and placed in a biohazard bag.The screw was inspected to make sure it was full.All scrubbed employees were re-gloved and the case went on.Risk was called and informed of what was going on.The rongeur was placed in the risk bin at the operating room front desk.

• Brand Name: TELEFLEX PILLING WECK RONGUER
• Type of Device: RONGEUR
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6137770
• MDR Text Key: 61209817
• Report Number: 6137770
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 386160
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR