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

Model Number	71362935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the surgeon started to drill for screw and drill snapped and bent completely sideways.Backup device available.No more information available.

• Brand Name: FLEXIBLE DRILL 35MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9142517
• Report Number: 1020279-2019-03534
• Device Sequence Number: 3123126
• Product Code: JDG
• UDI-Device Identifier: 03596010464668
• UDI-Public: 03596010464668
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71362935
• Device Catalogue Number: 71362935
• Device Lot Number: 19DSC0008
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1