MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX ACCESS POSITIONING SYSTEM; SUPPORT, PATIENT POSITION

Model Number	72205101
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the acufex positioning system was not holding internal or external rotation.No case or patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and a missing button plug was observed.A functional evaluation did not reveal any problems.The unit passed the rotation torque test.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review did not find any related failures.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a failure of the reel torque insert in the quick connect.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: ACUFEX ACCESS POSITIONING SYSTEM
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10177261
• Report Number: 1643264-2020-00394
• Device Sequence Number: 14093385
• Product Code: CCX
• UDI-Device Identifier: 00885556715116
• UDI-Public: 00885556715116
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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 Model Number: 72205101
• Device Catalogue Number: 72205101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/21/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1