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

Catalog Number	7210569S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the spider has leaks of pressure oil during the surgery, this can cause loss of traction.No further information is available.
Additional Manufacturer Narrative
The device 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 that the unit had excessive oil at the dumbbell joint.The unit failed the 50 pound weight test.The primary failure was at the dumbbell joint.The piston migration was checked and measured to be 2.44 inches, which is indicative of significant hydraulic fluid loss.The complaint was confirmed and the root cause has been determined to be excessive oil loss caused by a bad seal within the dumbbell joint.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Event or Problem Description
It was reported that during the surgery, the spider had leaks of pressure oil, which is a failure that could cause loss of patient position or joint distension.There was no delay or patient injuries reported.No further information is available.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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 6512
• MDR Report Key: 7873897
• Report Number: 1643264-2018-00697
• Device Sequence Number: 2347461
• Product Code: FWZ
• UDI-Device Identifier: 03596010647757
• UDI-Public: (01)03596010647757
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2018

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 Catalogue Number: 7210569S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 12/04/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/30/2018; 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1