MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN TROCHANTERIC ANTEGRADE NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Trigen tan nail implanted (b)(6) 2016.Patient has now presented at hospital with broken nail through most distal of proximal recon mode screw holes.Also one of the 2 cables used has broken.Revision was scheduled for (b)(6) 2016 but is not confirmed yet.

• Brand Name: TRIGEN TROCHANTERIC ANTEGRADE NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6204336
• MDR Text Key: 63259454
• Report Number: 1020279-2016-00984
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• 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
• Treatment: CABELS, ARTICLE DATA: NI
• Patient Outcome(s): Required Intervention