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

Model Number 71631161

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).

Event 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
• Type of Device: 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
• MDR Text Key: 315785179
• Report Number: 1020279-2023-01105
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 03596010478450
• UDI-Public: 03596010478450
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 71631161
• Device Catalogue Number: 71631161
• Device Lot Number: 08KNM0007
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1