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

Model Number 7210569

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arm and shoulder procedure, the hydraulic system of the spider limb positioner would not hold the position.The procedure was successfully completed with a surgical delay greater than 30 minutes, using an alternative device and with a change in the surgical technique; the shoulder of the patient had to be manipulated in the air by getting an additional staff member.No further complications were reported.

Manufacturer Narrative

H10: h3, h6: the reported 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.No issues were noted.A functional evaluation was performed.The device failed the weight test.The piston migration was at 1.8 inches.There was pooling oil on the bimba cylinder and inside it's cover.There was no obvious wear or damage to the amplifier piston inner seals.The complaint was confirmed, and the root cause has been associated with a seal failure.A seal failure can result in the loss of oil and prevent the device from properly pressurizing and holding position.A review of device records shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately.There were no indications to suggest the anticipated risk is not adequate.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.No containment or corrective actions are recommended at this time.

• Brand Name: POSITIONER SPIDER LIMB
• Type of Device: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15254328
• MDR Text Key: 298195777
• Report Number: 1643264-2022-00284
• Device Sequence Number: 1
• Product Code: FWZ
• UDI-Device Identifier: 03596010511201
• UDI-Public: 03596010511201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210569
• Device Catalogue Number: 7210569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention