MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER FOR JAPANESE/ESCHMANN OR TABLE; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number	72200917
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fixation of spider arm was loose.No case involved.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 a missing bolt on the clamp assembly was noted.A functional evaluation revealed that the device failed the weight test.The piston migration was at 2.2 inches, which is indicative of hydraulic fluid loss.The reported failure was confirmed and the root cause has been determined to be a seal failure.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 this was a repeat issue.

• Brand Name: SPIDER FOR JAPANESE/ESCHMANN OR TABLE
• 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: 10589819
• Report Number: 1643264-2020-01305
• Device Sequence Number: 2822342
• Product Code: FWZ
• UDI-Device Identifier: 00885554012910
• UDI-Public: 885554012910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 72200917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1