MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MULTIPURPOSE DRIVER; DRIVER, PROSTHESIS

Model Number	71631161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, the end of a multipurpose driver broke while trying to remove a screw from an intertan nail that was causing the patient pain.A midas-rex burr was used to cut screws from the patient's bone so that they were no longer protruding.Patient's current health status is unknown.

• Brand Name: MULTIPURPOSE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16986740
• Report Number: 1020279-2023-01105
• Device Sequence Number: 6771773
• Product Code: HWR
• UDI-Device Identifier: 03596010478450
• UDI-Public: 03596010478450
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 71631161
• Device Catalogue Number: 71631161
• Device Lot Number: 08KNM0007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown