MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTELLIO LINK WEREWOLF; MEDICAL DEVICE DATA SYSTEM

Catalog Number 72205191

Device Problem Connection Problem (2900)

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

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-2020-00028144-1.

Event Description

It was reported that during set up the intelio link werewolf did not connect.There was a change in surgical technique however no delay or patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review was performed and found without the requested clinical information a thorough medical investigation cannot be rendered.It is unknown how the procedure was completed.The patient impact could not be determined based on the limited information provided.Should any additional clinical information be provided this complaint will be re-evaluated.No further clinical/medical assessment is warranted at this time.A review of the device history records show 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 an isolated event.Visual inspection observed the back label for configure or use setting switch is missing.Functional evaluation revealed after an extended time, the unit does not show signs of connecting to the wifi or the werewolf, neither the wifi led or the data led illuminate.The unit was opened and found no issues.The complaint was confirmed and the root cause is associated with a component failure.Factors, which could have contributed to the complaint event, include, failure of an internal component which could cause the device to not activate or send a wireless signal or failure of the internal pcb.No containment or corrective actions are recommended at this time.

• Brand Name: INTELLIO LINK WEREWOLF
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• 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: 10929850
• MDR Text Key: 219103935
• Report Number: 1643264-2020-01973
• Device Sequence Number: 1
• Product Code: OUG
• UDI-Device Identifier: 00885556741641
• UDI-Public: 885556741641
• 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: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72205191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2022
• 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