MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 125D; NAIL, FIXATION, BONE

Catalog Number 71934479

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal reference number: (b)(4).

Event Description

It was reported that, after an internal fixation surgery had been performed on (b)(6) 2023, the patient experienced proximal portion breakage of the nail.This adverse event was addressed by revision surgery on (b)(6) 2024, in which the entire nail was removed.Surgeon then went to remove the compression screw, which then realized the tip was broken off.He was able to remove the compression screw by sliding an osteotome inferior to the compression screw to create some space, and then he slid that same osteotome in between the lag and compression screw to separate them.He removed the lag screw and pulled the remaining compression screw out with a bulldog.He then used a stryker nail extractor to get the rest of the nail out.Patient's current health status is unknown.

Manufacturer Narrative

H10.Additional information in d1, d2, d4 and d9.

• Brand Name: INTERTAN 10MM X 24CM 125D
• Type of Device: NAIL, FIXATION, BONE
• 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: 18927060
• MDR Text Key: 337944761
• Report Number: 1020279-2024-00558
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556105092
• UDI-Public: 00885556105092
• 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,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2023
• Device Catalogue Number: 71934479
• Device Lot Number: 23GM06285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention