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

Catalog Number	7210569
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code (b)(6).The reported 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.The arm labels were damaged. the device had an aluminum dumbbell.The battery terminal was damaged.A functional evaluation was performed. the device failed the weight test.The piston migration was at.58 inches.The reported complaint was confirmed and the root cause has been associated with a stress problem.The evaluated failure of a failed weight test has a root cause that has been associated with a seal  failure. 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.A complaint history review concluded this was a repeat issue.  internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that the spider ii positioner has been returned from repair, but on checking the equipment it was discovered that the battery will not load in to the positioner.Two different batteries have been tried.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit failed weight test which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 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.The arm labels were damaged.The device had an aluminum dumbbell.The battery terminal was damaged.A functional evaluation was performed.The device failed the weight test.The piston migration was at.58 inches.The reported complaint was confirmed and the root cause has been associated with a stress problem.The evaluated failure of a failed weight test has a root cause that has been associated with a seal failure.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.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: 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: 11474124
• Report Number: 1643264-2021-00979
• Device Sequence Number: 17063555
• Product Code: FWZ
• UDI-Device Identifier: 03596010511201
• UDI-Public: 3596010511201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 7210569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1