MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX ACCESS LATERAL TRACTION BOOM; SUPPORT, PATIENT POSITION

Model Number	72205103
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while testing the acufex access lateral traction boom is down, the blue ring won't lock.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3,h6: the device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed no issues.A functional evaluation found that the blue ring wouldn't lock due to a polishing stone from manufacturing being stuck in the quick connect locking channel.The complaint was confirmed.Factors that could have contributed to the reported event include an inadvertent lodging of a loose polishing stone in the locking channel after polishing.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.
Additional Manufacturer Narrative
H10: h2, h3, h6.The device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed no issues.A functional evaluation found that the blue ring wouldn't lock due to a polishing stone from manufacturing being stuck in the quick connect locking channel.The complaint was confirmed.Factors that could have contributed to the reported event include an inadvertent lodging of a loose polishing stone in the locking channel after polishing.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 review of this devices manufacturing process showed that the push button must be checked for free movement and that it locks the top plate.A complaint history review did not find any related failures.A corrective action in the form of a complaint notification has been issued to the manufacturing group regarding this issue.

• Brand Name: ACUFEX ACCESS LATERAL TRACTION BOOM
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10151139
• Report Number: 1643264-2020-00339
• Device Sequence Number: 11655930
• Product Code: CCX
• UDI-Device Identifier: 00885556715123
• UDI-Public: 00885556715123
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 12/08/2020

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: 72205103
• Device Catalogue Number: 72205103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 07/06/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/09/2020; 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1