MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD TRIAL 12/14 40 -4; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71366516
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a malfunction in which the inside of trial head (40mm -4) clip that locks into 12/14 taper on femoral trial neck broke off.The broken part was retrieved from the patient.
Additional Manufacturer Narrative
The femoral head trail and its pieces were returned and evaluated.A visual inspection confirmed the complaint that one of the tabs inside of the trial that allows it to mate with a femoral head has fractured.Additionally, the articular surface of the trial exhibits material deformation consistent with regular use.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit has been issued for this device.

• Brand Name: FEMORAL HEAD TRIAL 12/14 40 -4
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7808533
• Report Number: 1020279-2018-01616
• Device Sequence Number: 11075014
• Product Code: MDM
• UDI-Device Identifier: 00885556110126
• UDI-Public: 00885556110126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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 Catalogue Number: 71366516
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1