MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL SPIDER 2 TENET 7615; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	72203299S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
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 it was noted that the unit was received in a pressurized state.A functional evaluation revealed that the dumbbell joint was very difficult to move after depressurization.The dumbbell joint was disassembled and pronounced wear marks were noted on the pressure rings.These wear marks prevented the smooth manipulation of the spider 2 limb at the dumbbell joint.The hardened chrome dumbbell showed no signs of scratching or chipping.The complaint was confirmed and the root cause has been determined to be worn pressure rings not allowing smooth movement of 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 it was found the ball joint closest to the spider is sticking even when unlocked.When tested it can be forced loose without too much effort but more than the providers would like.It has problems to be positioned properly.No patient injury was reported.

• Brand Name: SVCE REPL SPIDER 2 TENET 7615
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7795928
• Report Number: 1643264-2018-00619
• Device Sequence Number: 19455087
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: (01)00885554029673
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 08/18/2018

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: 72203299S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1