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

Catalog Number	7210577
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the accessory, traction wont rotate; 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
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 was performed on the product and no issues were noted.A functional evaluation revealed the rotational collar would not rotate.The reported failure was confirmed and the root cause has been associated with a component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include material degradation after repeated autoclave cycles.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.

• 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: 10463189
• Report Number: 1643264-2020-00989
• Device Sequence Number: 2344313
• Product Code: FWZ
• UDI-Device Identifier: 03596010511256
• UDI-Public: 3596010511256
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 09/17/2020

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 Catalogue Number: 7210577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1