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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The handle on the threaded ring was bent. a functional evaluation was performed.The air swivel had a leak.The device wouldn't hold pressure.The piston migration was at 2.4 inches.The reported complaint was confirmed and the root cause has been associated with a seal failure.The evaluated failure of "won't hold pressure" can also be attributed to a seal failure.An analysis of the enclosed image appears to show a spider 1.The swivel connector appears to be covered in gauze.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 that "not holding pressure" is a repeat issue.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, the spider limb positioner was broken.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit was not holding pressure which makes it a reportable event.

• 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: 11939450
• Report Number: 1643264-2021-02066
• Device Sequence Number: 4226376
• Product Code: FWZ
• UDI-Device Identifier: 03596010511201
• UDI-Public: 3596010511201
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 06/04/2021

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: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1