MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN; NAIL

Catalog Number 71655030

Device Problems Connection Problem (2900); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 10/25/2014

Event Type  Injury  

Event Description

It was reported that surgery was delayed due to the surgeon having trouble getting the screw to connect in the proximal hole.

• Brand Name: TRIGEN
• Type of Device: NAIL
• 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: melanie travis ; 1450 brooks road; memphis, TN 38116 ; 9013996233
• MDR Report Key: 4241624
• MDR Text Key: 4989591
• Report Number: 1020279-2014-00686
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 71655030
• Device Lot Number: 14DT41525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization