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

Catalog Number	72202019
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a humerus fracture surgery, after the minitac ultrabraid anchor was implanted, the screw was loosened.The device was successfully retrieved from the patient with the help of tweezers and suction.The procedure was finished with a smith and nephew back up device used in an additionally drilled bone hole, and there was a void left in the patient.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device, suture strings and anchor were returned with biological debris on them.A functional assessment of the device found it functions as designed.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 similar reported events.The instructions for use were 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.A clinical review states the provided undated photo of the explant does not contribute to the clinical investigation of the root cause of the reported loosening of the anchor.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• 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: 18192101
• Report Number: 1219602-2023-02267
• Device Sequence Number: 17951376
• 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
• Serviced by Third Party (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
• Report Date (Section B): 02/25/2024

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 Catalogue Number: 72202019
• Device Lot Number: 2086809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male