MAUDE Adverse Event Report: SMITH & NEPHEW INC, ENDOSCOPY DIVISION SMITH AND NEPHEW ORTHOPAEDICS DRILL BIT; BIT, DRILL

Catalog Number 0086

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2021

Event Type  malfunction  

Event Description

Tip of drill bit broke off during procedure and was retained in the tibial intramedullary canal.

• Brand Name: SMITH AND NEPHEW ORTHOPAEDICS DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW INC, ENDOSCOPY DIVISION; andover MA
• MDR Report Key: 12149714
• MDR Text Key: 261232600
• Report Number: MW5102449
• Device Sequence Number: 1
• Product Code: HTW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0086
• Device Lot Number: 21175023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 42