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

Catalog Number	72201725
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the plate broke off.There was patient involved, the same device was able to be used and the procedure was delayed for more than 60 minutes.No patient injury or other complications were reported.
Additional Manufacturer Narrative
An evaluation was performed by smith and nephew and could confirm the customer complaint for the plate broke off.A visual inspection was performed and showed the plate is physically broken, appears to have been dropped or banged.This most likely happened prior to the procedure, leaving only a slight crack or weakness until weight and pressure fully opened the break.The root cause was determined to be handling damage.No manufacturing related defects were observed.
Event or Problem Description
It was reported that during hip arthroscopy, the plate broke off.The patient was under anesthesia as the failure occurred.The same device was able to be used.The staff used an additional 30-45 minutes trying to position the patient properly despite of the broken table.No injuries were reported and no instruments had been introduced inside the patient.

• Brand Name: SUPINE TABLE ATTACHMENT (A2) W/PAD
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8410461
• Report Number: 3003604053-2019-00031
• Device Sequence Number: 16605849
• Product Code: HST
• UDI-Device Identifier: 03596010612816
• UDI-Public: 03596010612816
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 72201725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1