MAUDE Adverse Event Report: SMITH & NEPHEW INC. TRIGEN INTERTAN SMITH AND NEPHEW; TRAY, SURGICAL, INSTRUMENT

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2022

Event Type  Injury  

Event Description

Smith and nephew trigen intertan trochanteric nail was used on an inter trochanteric fracture.Nail broke at proximal interlocking hole which had to be fixed with a different device.Fda safety report id # (b)(4).

• Brand Name: TRIGEN INTERTAN SMITH AND NEPHEW
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW INC.
• MDR Report Key: 13506520
• MDR Text Key: 285474323
• Report Number: MW5107357
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Life Threatening; Disability; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White