MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB POSITIONER SPIDER LIMB; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210569F
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spider tenet was not holding pressure.No case was involved.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 was performed on the product and a missing quick connect spring was noted.A functional evaluation revealed that the unit had excessive oil within the bimba tube housing.The unit failed the weight test.The piston migration was at 2.42 inches.The reported failure was confirmed and the root cause has been determined to be seal failure.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: RFB POSITIONER SPIDER LIMB
• 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: 10500354
• Report Number: 1643264-2020-01082
• Device Sequence Number: 11542870
• Product Code: FWZ
• UDI-Device Identifier: 03596010658500
• UDI-Public: 03596010658500
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 10/08/2020

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: 7210569F
• Device Catalogue Number: 7210569F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1