MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT INVISIKNOT ANKLE FRACTURE; WASHER, BOLT NUT

Model Number	72204834
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during surgery, the packaging of the invisiknot ankle fracture tore when it was going to be used and it got unsterile.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The clear plastic packaging has been torn up from the bottom.It ripped away from the poly backing about 1/4 of the way up from the bottom of the package.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of packaging sequence found that operator must verify that the pouches are free of pin holes, cuts, particles and supplier seal defects, and in addition, when sealing the pouches every pouch must be inspected.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include applying excessive force during package removal or rough handling.No containment or corrective actions are recommended at this time.

• Brand Name: KIT INVISIKNOT ANKLE FRACTURE
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12380014
• Report Number: 1219602-2021-01805
• Device Sequence Number: 4333332
• Product Code: HTN
• UDI-Device Identifier: 00885556640227
• UDI-Public: 00885556640227
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K162996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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 Expiration Date: 05/26/2026
• Device Model Number: 72204834
• Device Catalogue Number: 72204834
• Device Lot Number: 50942919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown