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

Model Number	012014
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7185122
• Report Number: 1219602-2018-00063
• Device Sequence Number: 72978
• Product Code: NBH
• UDI-Device Identifier: 03596010023360
• UDI-Public: (01)03596010023360(10)50666901
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/30/2018; 03/12/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/06/2018; 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1