MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA-DUMMY IMPLANT; NAIL IMPLANT

Device Problem Insufficient Information (3190)

Patient Problem Peeling (1999)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

As the specialist inserted the guide through the reduction nail to reduce the fracture, it began to bleed abundantly.Surgeon suspended the reduction to control it but can not locate the point of bleeding and requested the intervention of the vascular surgeon.The vascular surgeon checked but does not find the point of bleeding, and made a tamponade with gauze.The surgery was completed once the nail was implanted.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

• Brand Name: TRAUMA-DUMMY IMPLANT
• Type of Device: NAIL IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 9013995009
• MDR Report Key: 6187677
• MDR Text Key: 62793913
• Report Number: 1020279-2016-00976
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• 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): Hospitalization; Other
• Patient Age: 75 YR