MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.5 DRILL BIT {} QC 180/155 GOLD

Catalog Number 71176026

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2015

Event Type  Injury  

Event Description

It was reported that the tip of the drill bit broke off and became stuck in the right distal fibula.The broken tip was left in the patient.

Manufacturer Narrative

The complaint device was not returned and a lot/batch number was not provided.Also no clinical information was provided for our review.Without this information we cannot confirm the complaint or determine a root cause in our investigation.As such, we consider this investigation closed.Should the device or new information become available then we will re-open the investigation.No further actions are being taken at this time.

• Brand Name: 2.5 DRILL BIT {} QC 180/155 GOLD
• Type of Device: DRILL BIT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4962082
• MDR Text Key: 6190715
• Report Number: 1020279-2015-00535
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71176026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR