MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 11.5MM X 42CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71649742

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problem Injury (2348)

Event Date 06/12/2020

Event Type  Injury  

Event Description

It was reported that a patient with a 1/3rd femur fracture was operated on (b)(6) 2020. Metatan nail (11. 5mm x 42cm) was inserted with 85mm/80mm lag/compression screws and 35mm & 40mm distal screws. During the insertion, whilst drilling with the starter drill for the compression screw, the tip of the starter drill broke off. The surgeon, with a little effort, managed to remove the broken off tip of the proximal lag screw. The screw/screwdriver seemed to be catching on something but the screw was inserted. No problem inserting the compression screw. Lateral post-op x-ray shows that the lag/compression screw combination has missed the nail. The patient was operated again (b)(6) 2020. The surgeon removed the misplaced lag/compression screws, attached the metatan jig without removing the distal screws or nail and reinserted new proximal screws (product code 71642680, batch no 19dt19274) without incident. The same instrument set was used (b)(6) 2020 as was used (b)(6) 2020.

• Brand Name: META-TAN 11.5MM X 42CM LEFT
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10252411
• MDR Text Key: 198163693
• Report Number: 1020279-2020-03015
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 71649742
• Device Lot Number: 18JT09547
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 07/09/2020 Patient Sequence Number: 1