MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 36CM; TRIGEN RETROGRADE TIBIAL NAILS

Catalog Number 71655136

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a surgical delay of 45 minutes occurred in order to remove the ball tip guide rod which got stick in the nail and couldn't be withdrawn.Several attempts were made to pull the ball tip guide rod out but all attempts were unsuccessful.As such the whole nail and nail assembly had to be withdrawn from the patient and was deemed unusable for the procedure.A new guide rod was opened and a new nail was opened and the procedure was completed using these new products.

• Brand Name: META-NAIL TIBIAL 10MM X 36CM
• Type of Device: TRIGEN RETROGRADE TIBIAL NAILS
• 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: 5812106
• MDR Text Key: 50959166
• Report Number: 1020279-2016-00562
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K061019
• 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: 07/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71655136
• Device Lot Number: 16BT64514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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