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

Catalog Number	7210569S
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the positioner arms don't get fixed well.When pressed, the spider's arm falls down.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the 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 it was noted that a non- smith and nephew clamp had been used to attach an air nozzle to an air hose attached to the footswitch.A functional evaluation revealed that the unit had excessive oil within the bimba tube housing as well as on the bimba itself.The amplifier piston seal had failed and allowed oil to seep into the bimba housing.The unit also failed the 50 pound weight test.The piston migration was at 3.25 inches, which is indicative of hydraulic fluid loss.The complaint of was confirmed and the root cause has been determined to be excessive oil loss caused by a bad seal within the amplifier piston.

• 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: 10077381
• Report Number: 1643264-2020-00247
• Device Sequence Number: 16868911
• Product Code: FWZ
• UDI-Device Identifier: 03596010647757
• UDI-Public: 3596010647757
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other
• Type of Report: Initial,Followup
• 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: 7210569S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement 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