MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIAL REMOVAL HANDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71360920
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when surgeon was removing stem, handle broke.All pieces were retrieved, no delay, no injury.
Additional Manufacturer Narrative
The affected trial removal handle was returned and evaluated.A visual inspection of the product confirmed the stated failure.A portion of the orange handle has fractured off.The broken piece is not returned with this complaint.This device was manufactured in 2012 and it shows signs of significant wear and usage.Our investigation included a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: TRIAL REMOVAL HANDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8173820
• Report Number: 1020279-2018-02819
• Device Sequence Number: 1706190
• Product Code: MDM
• UDI-Device Identifier: 03596010535252
• UDI-Public: 03596010535252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 71360920
• Device Lot Number: 12GSY0001
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1