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	10/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in a spider tenet the upper most arm is very stiff.No patient injury reported.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and a cracked enclosure was observed.A functional evaluation revealed stiff operation of the hinge joint.The joint was disassembled and it was discovered that the hinge joint retainer was warped which caused extra friction within the joint.The complaint was confirmed and the root cause has been associated with a warped hinge joint retainer.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.

• 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: 6933284
• Report Number: 1643264-2017-00608
• Device Sequence Number: 873310
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: (01)00885554029673
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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: 10/12/2017
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR