MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUPINE TABLE ATTACHMENT (A2) W/PAD; APPARATUS, TRACTION, NON-POWERED

Model Number 72201725

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

It was reported that during arthroscopy, the leg holder detached from the table attachment when traction was applied to the operative leg, despite all required checks being carried out prior to surgery.There was a delay of under 30 min and the procedure was completed using the same device and standard supine technique.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SUPINE TABLE ATTACHMENT (A2) W/PAD
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10547153
• MDR Text Key: 207338456
• Report Number: 3003604053-2020-00109
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 03596010612816
• UDI-Public: 03596010612816
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201725
• Device Catalogue Number: 72201725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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