MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 5 8MM; TEMPLATE

Catalog Number	00584102508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the poly trial cracked down the middle.No injuries or delays reported.Backup device available.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection confirms the trial has a large crack in it.The device does have multiple scratches and burrs in the plastic.The device shows significant signs of wear usage.This instrument was manufactured in 2015.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 5 8MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9104535
• Report Number: 1020279-2019-03452
• Device Sequence Number: 11292599
• Product Code: HWT
• UDI-Device Identifier: 00885556619568
• UDI-Public: 00885556619568
• 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): 11/08/2019

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: 00584102508
• Device Lot Number: 63243102
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1