MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROX STR HUMERAL NAIL 8/7 X 16; TRIGEN HUMERAL NAIL SYSTEM

Catalog Number 71760816

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported the surgeon left the nail inside the medullary space during a planned removal surgery.The guide bolt instrument was unable to attach to the nail for removal.

Manufacturer Narrative

The associated complaint device was not returned.The device remains implanted.

• Brand Name: PROX STR HUMERAL NAIL 8/7 X 16
• Type of Device: TRIGEN HUMERAL NAIL SYSTEM
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5818745
• MDR Text Key: 50310823
• Report Number: 1020279-2016-00567
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71760816
• Device Lot Number: 15DM13235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2015
• 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; Required Intervention