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

Model Number 2274-45-500

Device Problem Break (1069)

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

Event Date 09/27/2019

Event Type  malfunction  

Event Description

At 0900, a 45 mm drill bit broke while being utilized.All pieces recovered and equipment removed from field.Per policy radiology films obtained and negative per radiologist.

• Brand Name: QUICKSET
• Type of Device: BIT, DRILL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 9179108
• MDR Text Key: 161967240
• Report Number: 9179108
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109211
• UDI-Public: (01)10603295109211
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2274-45-500
• Device Catalogue Number: 227445500
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 92