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

Catalog Number	72205191
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-2020-00028144-1.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1643264-2020-01973
• Device Sequence Number: 2539221
• Product Code: OUG
• UDI-Device Identifier: 00885556741641
• UDI-Public: 885556741641
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 72205191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown