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

Catalog Number	7210569
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 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 observed.A functional evaluation revealed the device failed the weight test.The complaint was confirmed and the root cause has been associated with a seal failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include deterioration of the seal material over time or an abnormality of the surface that the seal contacts.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.A complaint history review found related failures.This failure mode will be trended to assess for any necessary corrective actions.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that the spider limb was not working.It is unknown whether the event happened during surgery and if there was a patient involvement.Results of investigation have concluded that this unit failed the weight test which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SVC REPL 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: 10254711
• Report Number: 1643264-2020-00513
• Device Sequence Number: 2852941
• Product Code: FWZ
• UDI-Device Identifier: 03596010647757
• UDI-Public: 3596010647757
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/09/2020

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: 7210569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1