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

Model Number	72205103
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during the surgery the distal attachment of the acufex access where the sterile drapes attach was not securing or releasing as it should.No significant delay or other complications reported.Alternate positioning devices where used in order to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).The reported device, used in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.A review of the device history records showed there were 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 for similar confirmed complaints associated with this part number did not identify any prior similar events.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.The acufex access positioning system ifu warns, ¿prior to each use, inspect the acufex access positioning system and components for damage.¿ a review of the acufex access positioning system risk management files was performed and found multiple line items addressing this failure mode.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 11027841
• Report Number: 1643264-2020-02111
• Device Sequence Number: 1087968
• 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: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: 72205103
• Device Catalogue Number: 72205103
• Device Lot Number: 50876272
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention