MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 6 8MM; TEMPLATE

Catalog Number	00584102608
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery it was tried to put in trial poly but it broke in half.No delay reported.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the articular surface provisional indicated it fractured in half, confirming the stated complaint.This device was manufactured over 23 years ago; is worn and shows significant signs of use.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; 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.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 6 8MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8265738
• Report Number: 1020279-2019-00225
• Device Sequence Number: 2120510
• Product Code: HWT
• UDI-Device Identifier: 00885556619629
• UDI-Public: 00885556619629
• 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): 03/13/2019

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: 00584102608
• Device Lot Number: 62619613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1