MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET SCREW DRIVER; SCREWDRIVER

Catalog Number 71665014

Device Problem Fracture (1260)

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

Event Date 12/02/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number: (b)(4).

Event Description

It was reported that during an intertan case, a set screw driver broke while tightening the set screw.All pieces retrieved.There was nothing left in the patient.The set screw driver broke after it was used to tighten the screw.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

• Brand Name: SET SCREW DRIVER
• Type of Device: SCREWDRIVER
• 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: 18389810
• MDR Text Key: 331515011
• Report Number: 1020279-2023-02577
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2023

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 Catalogue Number: 71665014
• Device Lot Number: 15MCT0015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2023
• Initial Date FDA Received: 12/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1