MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MNITAC 2.0 TI W/NDL 22-0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72202019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Post Operative Wound Infection (2446); Osteomyelitis (4533)
Date of Event	09/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that 3 years after a surgery in the left index finger were a minitac was used, the patient presented redness and pain.Antibiotics and anti-inflammatories were prescribed.The event was not resolved and the patient had increased pain.The event was treated with surgery to remove the screw, as well as the bone marrow around since it was found to be infected and necrotic.The patient is in good condition now.
Additional Manufacturer Narrative
H11: h2: correction on h6 (health effect - clinical code and type of investigation).
Additional Manufacturer Narrative
H10: 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 no 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No wound cultures were provided.Two undated/unlabeled left hand x-rays images and two fluoroscopic views of the left hand were provided and confirm the placement of the minitac anchor.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The patient impact beyond the reported, symptoms, necrosis and additional surgery with screw removal cannot be determined.Therefore, no further clinical/medical assessment is warranted.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.H11: h2: correction on h6 (health effect - clinical code).

• Brand Name: MNITAC 2.0 TI W/NDL 22-0 ULTRABRAID
• Common Device Name: STAPLE, 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: 15929534
• Report Number: 1219602-2022-01920
• Device Sequence Number: 6797959
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: 03596010619013
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2023

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 Expiration Date: 08/21/2022
• Device Model Number: 72202019
• Device Catalogue Number: 72202019
• Device Lot Number: 50680863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 01/03/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/05/2023
• Date Device Manufactured: 08/21/2017
• 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: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female