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

Model Number	72204834
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191); Insufficient Information (4580)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the first operative appointment on (b)(6) 2020, it was found that the invisiknot broke at the tib/fib joint.The patient was sent to surgery again on (b)(6) 2020 to remove this invisiknot and replace with a smith and nephew screw.The broken pieces were removed with tweezers.He ankle was revised and another screw was removed and two syndesmotic screws were added.The procedure was completed without a significant delay.The current status of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H2: additional information ¿a2, e3, h6: health effect - clinical code, health effect - impact code¿ h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Per e-mail communication during the revision the removal of the broken invisiknot took five minutes and two syndesmotic screws were implanted to replace the invisiknot.Although requested, the surgical reports were not provided.Two undated x-ray photos were provided for review which only show the invisiknot washer but no root cause can be concluded.Conclusion: the x-ray photo alone no conclusion can be made on the root cause of the event.Based on the limited information provided and without the return of the device the root cause of the reported breakage could not be determined.The impact to the patient beyond the revision cannot be concluded.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of the customer provided image revealed the ultratape suture of the medial button was cut from the lateral plug and the device was removed from the patient.Insufficient information was provided, thus a manufacturing record review could not be performed.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product identification information was provided, and thus, a complaint history review by batch could not be conducted.A complaint history review by product number found no similar reported events.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 review of the ultratape specification revealed each shipment of material must be accompanied by the manufacturer's certificate of conformance.Width, thickness, braid density, fiber tenacity and usp testing for knot break strength to be certified.The suture must be free of frays and defects and any defects are to be cut and removed.There was a relationship found between the device and the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.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: 10807255
• Report Number: 1219602-2020-01795
• Device Sequence Number: 4178113
• Product Code: HTN
• UDI-Device Identifier: 00885556640227
• UDI-Public: 00885556640227
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72204834
• Device Catalogue Number: 72204834
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 112 KG