MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 3 9MM; TEMPLATE

Model Number 00584102309

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2020

Event Type  Injury  

Event Description

It was reported that, during inspection, articular surface provisional size 3 9mm was noticed to be broke in half and laying at the bottom of the tray.No case involved.

Manufacturer Narrative

The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is broken in half, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 3 9MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10844160
• MDR Text Key: 216386321
• Report Number: 1020279-2020-06474
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00885556619452
• UDI-Public: 00885556619452
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00584102309
• Device Catalogue Number: 00584102309
• Device Lot Number: 60174648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1