MAUDE Adverse Event Report: DEPUY SYNTHES /DEPUY ORTHOPAEDICS, INC. DRILL BIT; BIT, DRILL

Catalog Number 03.130.300

Device Problems Break (1069); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2022

Event Type  malfunction  

Event Description

A 1.5mm drill bit (depuy synthes reference 03.130.300) broke during use.The room and sterile field was searched, but we were unable to find the broken piece.The surgeon was aware and believes it's still inside the patient based on the intraoperative xray image.The remaining broken drill bit was sent down to spd for cleaning and for risk management.

• Brand Name: DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): DEPUY SYNTHES /DEPUY ORTHOPAEDICS, INC.; warsaw IN 46582
• MDR Report Key: 16323683
• MDR Text Key: 309270594
• Report Number: MW5114769
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.130.300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male