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

Model Number	7210577
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no complaint related issues were noted.A functional evaluation revealed the adjustment collar was very hard to turn and squeaked loudly.The adjustment collar was disassembled.The threads of the adjustment collar had graphite on them that was applied at manufacture.The graphite also had a lighter colored residue mixed in with it.This mixture hampered the smooth rotation of the adjustment collar.The complaint was confirmed and the root cause has been attributed to a breakdown of the adjustment collar lubricating graphite.This was augmented by the infiltration of a chemical into the adjustment collar housing mixing with the graphite.This prevented the smooth rotation of the adjustment collar.
Event or Problem Description
It was reported that the device does not holding traction.No patient injuries were reported.

• 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 6512
• MDR Report Key: 7637797
• Report Number: 1643264-2018-00500
• Device Sequence Number: 11217299
• Product Code: FWZ
• UDI-Device Identifier: 03596010511256
• UDI-Public: (01)03596010511256
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: 06/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1