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

Model Number 00584102508

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that the poly trial broke while trialing.The incident occurred during use, while inside the patient.The procedure was completed using the same device.No surgical delay or injury to the patient was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 5 8MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10824994
• MDR Text Key: 215874054
• Report Number: 1020279-2020-06381
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00885556619568
• UDI-Public: 00885556619568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00584102508
• Device Catalogue Number: 00584102508
• Device Lot Number: 63395657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention