MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYNAMOMETRIC WIRE TENSIONER; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 103101

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

A device malfunction was identified that, upon reoccurrence, may necessitate medical intervention and/or result in an extended surgical delay.

• Brand Name: DYNAMOMETRIC WIRE TENSIONER
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: robert rust ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 7379282
• MDR Text Key: 103803882
• Report Number: 1020279-2018-00671
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103101
• Device Lot Number: 09FP01211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2016
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• Type of Device Usage: Reuse
• Patient Sequence Number: 1