MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION FLEXIBLE DRILL 35MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71362935

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

Drill was stressed at a difficult angle of drilling and broke the drill bit.

• Brand Name: REFLECTION FLEXIBLE DRILL 35MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15994946
• MDR Text Key: 305591975
• Report Number: 15994946
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71362935
• Device Catalogue Number: 71362935
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Sex: Female
• Patient Weight: 59 KG