MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STANDARD FEMORAL STEM 14; ACCESSORIES,ARTHROSCOPIC

Model Number 012014

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 12/20/2017

Event Type  malfunction  

Event Description

It was reported while the punch is used in soft tissue it makes a typical sound which is like facing an obstruction while cutting in the shaft.The surgeon said that it was an unusual sound and caused inconvenience while operating.There was no back up available.

Manufacturer Narrative

Due to no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.

Manufacturer Narrative

One 012014 duckbill 1.5mm upbiter basket punch returned.The device is a one year old reusable device.The complaint reads: ¿it was reported while the punch is used in soft tissue it makes a typical sound which is like facing an obstruction while cutting in the shaft.The surgeon said that it was an unusual sound and caused inconvenience while operating.¿ there are typical dings and surface scratches from normal use.The device is intended to make a light snip at the distal end of the tip.This was successful and cut as intended using simulated tissue test material.There is a slight pop as the biter punches through the material.This is very slight and does not affect form, fit or function.No root cause related to the manufacture of this device was determined.

• Brand Name: STANDARD FEMORAL STEM 14
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7185122
• MDR Text Key: 97381190
• Report Number: 1219602-2018-00063
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023360
• UDI-Public: (01)03596010023360(10)50666901
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

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 Model Number: 012014
• Device Catalogue Number: 12014
• Device Lot Number: 50666901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/30/2018; 03/12/2018
• Supplement Dates FDA Received: 02/06/2018; 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1