MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; REAMER

Catalog Number 11-8165

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/29/2017

Event Type  malfunction  

Event Description

During irrigation and debridement of left tibia, the surgeon was attempting to ream out the left tibia in an attempt to evacuate pus from the tibial canal.After pulling out the reamer from the tibial canal, it was noted the tip of the reamer was missing.An x-ray taken utilizing the c-arm revealed the tip of the reamer inside the tibial canal, the tip was successfully retrieved after a tibial window was created to retrieve the tip.There was no additional harm to the patient.

• Type of Device: REAMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms pkwy; cordova TN 38016
• MDR Report Key: 6803551
• MDR Text Key: 83014467
• Report Number: 6803551
• Device Sequence Number: 1
• Product Code: HTO
• 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: Patient
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 11-8165
• 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: 07/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2017
• 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: 36 YR