MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 10MM SET SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71642938

Device Problems Mechanical Jam (2983); Osseointegration Problem (3003)

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

Event Date 07/06/2021

Event Type  Injury  

Event Description

It was reported that, after surgery had been performed on (b)(6) 2019, and before a trigen meta tan removal, it was discovered that is not possible to remove the lag screw out due to no insertion of a compression screw. It was reported that the event will not be solved in order to protect the patient from re-fracturing the femur. Current health status of patient is unknown.

• Brand Name: META-TAN 10MM SET SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12311044
• MDR Text Key: 266160837
• Report Number: 1020279-2021-06306
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556343593
• UDI-Public: 00885556343593
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71642938
• Device Catalogue Number: 71642938
• Device Lot Number: 16BM04566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/11/2021 Patient Sequence Number: 1