MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN LEGION IMPLANT; PRSTHSISHIPHMITRNNOBARNGFMORLMTALPLYCTL

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pseudarthrosis (covered under (b)(4)).During explantation of the trigen intertan nail, the screw head on the compression screw broke off (covered under (b)(4)).The surgery had to be finished without removing the nail.

Manufacturer Narrative

It has been determined that this submission is a duplicate of mdrs 1020279-2020-01312 and 01313.Our results of investigation will be communicated via those mdrs.Please disregard this report.

• Brand Name: UNKNOWN LEGION IMPLANT
• Type of Device: PRSTHSISHIPHMITRNNOBARNGFMORLMTALPLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9955277
• MDR Text Key: 187511570
• Report Number: 1020279-2020-01290
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention