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

Model Number	7210569F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that the black lever to lock spider position broke off.The lever to tighten the spider mounting clamp to the surgical table accessory bar broke off at the weld.No case involved.Therefore, there was no patient involved.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 not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.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.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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 product evaluation was performed.The indexing handle and the handle of the circular clamp were broken off.The complaint was confirmed.Factors that could have contributed to the reported event include an application of excessive force or an impact event inconsistent with intended use.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: 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
• MDR Report Key: 11319771
• Report Number: 1643264-2021-00619
• Device Sequence Number: 3334643
• Product Code: FWZ
• UDI-Device Identifier: 03596010658500
• UDI-Public: 03596010658500
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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 Model Number: 7210569F
• Device Catalogue Number: 7210569F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 06/03/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/16/2021; 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1