MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 6MM X 25MM; SCREW, FIXATION, BONE

Model Number	72201769
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, on (b)(6) 2022, a patient was hospitalized due to a right foot varus deformity.A right calcaneus osteotomy, orthopedic internal fixation, transposition of the posterior cervical tendon, and contraction of the lateral ankle ligament were performed under general anesthesia, using a biosure anchor.On (b)(6) 2022, debridement was performed in the hospital because of "poor wound healing".The patient was discharged after healing.
Additional Manufacturer Narrative
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.There was no relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 device found the packages must be free of particulates above a threshold and the product is required to be 100% sterilized as of the date of this medical investigation, the information provided is insufficient to determine whether the patient¿s signs, symptoms outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.Based on the limited information provided, the impact to the patient beyond that which has already reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.The complaint was not confirmed.Factors that could have contributed to the reported event include insufficient or improper cleaning of the surgical site, or a biological response unrelated to the device.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: BIOSURE HA 6MM X 25MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 15806007
• Report Number: 1219602-2022-01741
• Device Sequence Number: 12165618
• Product Code: HWC
• UDI-Device Identifier: 03596010611659
• UDI-Public: 03596010611659
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Expiration Date: 04/20/2023
• Device Model Number: 72201769
• Device Catalogue Number: 72201769
• Device Lot Number: 50728843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/12/2022
• Date Device Manufactured: 04/20/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 11 YR
• Patient Sex: Male