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

Catalog Number	7210569F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
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 foot pedal was disconnected and not included with the unit.A functional evaluation revealed that the unit's indexing handle would continually rotate and not lock the clamp assembly into a stationary position.The clamp assembly's concave pin receptacles showed signs of extreme wear.The clamp body's convex pins also showed signs of wear.The issue of the indexing handle not holding position was confirmed and the root cause has been determined to be a combination of the clamp pins and the clamp's pin receptacles being worn which caused the indexing handle to continuously turn and not tighten the clamp assembly in place.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 the rotation lever will not lock.A backup device was available to complete the procedure with no delay or patient injuries.
Event or Problem Description
It was reported that the rotation lever will not lock.There was no loss of traction nor patient positioning while instruments were inside the patient.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.Initial report stated that the rotation lever of the device did not lock, being this a potential failure that can cause a loss of traction or positioning while instruments were inside the patient.However, reporter confirmed that this did not happen.So, reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Additional Manufacturer Narrative
Correction in the initial report, the date should be (b)(4) 2018.

• Brand Name: RFB 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: 8007267
• Report Number: 1643264-2018-00817
• Device Sequence Number: 1639905
• Product Code: FWZ
• UDI-Device Identifier: 03596010658500
• UDI-Public: 03596010658500
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/12/2018

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: 7210569F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/01/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 10/29/2018; 10/29/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 10/31/2018; 10/31/2018; 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1