MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 25MM; SCREW, FIXATION, BONE

Catalog Number	72201781
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Impaired Healing (2378)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that the incision site of a patient in which a biosure screw was used, would not heal.The patient had tibial wound dehiscing as well as superficial cellulitis and the skin macerated and soupy.It had 1 week of keflex and the incision closed two times.The cellulitis was resolved and the tissue surrounding the incision was debrided.The screw was removed from the patient.The patient was still having issues healing the incision site.The surgeon was not sure if it was the screw or if it¿s a complication with the closing suture.
Additional Manufacturer Narrative
H11: h2: corrected data: health effect - clinical and impact code.H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.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.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 clinical review states that based on the information provided, the clinical root cause of the reported event could not be determined.Wound dehiscence is considered a surgical complication, and this can happen due to various factors such as infection, poor surgical technique, or the patient's overall health.It cannot be concluded that the reported event is related to a malperformance of the implant.The patient impact is determined to be the healing issues at the incision site.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BIOSURE HA 9MM 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22627851
• Report Number: 1219602-2025-01872
• Device Sequence Number: 20909319
• Product Code: HWC
• UDI-Device Identifier: 03596010611772
• UDI-Public: 3596010611772
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: 72201781
• Device Lot Number: 51096442
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 01/09/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male