MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCESSORY TRACTION; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210577
Medical Device Problem Codes	Unstable (1667); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the release button of the "accessory traction" was not working, it looked bent and damaged, the clamp was not holding the bar anymore.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
Internal complaint reference (b)(4).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 that the quick connect button was bent, the clamp handle was worn and the rotational collar had wear marks.The set screw on the clamping handle was stripped.A functional evaluation was performed.There were no functional issues found.The device passed the weight test.The clamping assembly functioned properly.The quick connect assembly passed the rotational torque test.The quick connect assembly secured the test stand insert even with a bent release button.The complaint of a "damaged release button" was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with intended use.The reported failure of "the clamp not holding the bar" was not confirmed.Factors that could have contributed to this reported event include a damaged push button or missing spring.The device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded that both reported failures were repeat issues.

• Brand Name: ACCESSORY TRACTION
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10759971
• Report Number: 1643264-2020-01660
• Device Sequence Number: 3694054
• Product Code: FWZ
• UDI-Device Identifier: 03596010511256
• UDI-Public: 03596010511256
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 12/03/2020

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: 7210577
• Device Catalogue Number: 7210577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1