MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL SCREW; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

*us legal* it was reported that, after a trauma surgery on (b)(6) 2021 due to a subtrochanteric femur fracture.Plaintiff experiences severe pain.X-rays determined a breakage in the product.Ct revealed a periprosthetic subtrochanteric right femur fracture with varus alignment and nondisplaced intertrochanteric component.Physician noted the proximal aspect of the rod at the location of the proximal compression screw and the distal interlocking screw was fractured.Plaintiff underwent a revision surgery on (b)(6) 2021 to remove and replace the right femur and trigen meta tan trochanteric antegrade nail.It is unknown the status of the patient.

Event Description

It was reported that, after a trauma surgery on (b)(6) 2021 due to a sub trochanteric femur fracture.Plaintiff experiences severe pain.X-rays determined a breakage in the product.Ct revealed a periprosthetic sub trochanteric right femur fractur with varus alignment, nondisplaced intertrochanteric component, and nonunion.Physician noted the proximal aspect of the rod at the location of the proximal compression screw and the distal interlocking screw was fractured.Plaintiff underwent a revision surgery on (b)(6) 2021 to remove and replace the right femur and trigen meta tan trochanteric antegrade nail.It is unknown the status of the patient.

Manufacturer Narrative

H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: UNKN TRIGEN META-TAN TROCH ANTEGR NAIL SCREW
• 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: 14191585
• MDR Text Key: 289953227
• Report Number: 1020279-2022-01927
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 05/13/2022
• Supplement Dates FDA Received: 04/25/2022; 05/18/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Female