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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(6).
Event or Problem Description
It was reported that, during a wrist tfcc repair scope using the minitac, the first ultrabraid anchor was dislodged from the bone and the second suture anchor did not deploy.No significant delay and the procedure was completed by putting into a 19g needle, thereafter, the surgeon pierce the tendon using the needle and it passed the suture.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: part of the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.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.A visual inspection found the anchor separated is from the inserter with a piece of cut suture through the anchor.The remaining suture and needles were not returned.A functional evaluation revealed that the nose cone rotated properly.The complaint was not confirmed and the root cause could not be determined.Factors that could have contributed 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 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.

• 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: 12249277
• Report Number: 1219602-2021-01645
• Device Sequence Number: 8116906
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: 03596010619013
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2025
• Device Model Number: 72202019
• Device Catalogue Number: 72202019
• Device Lot Number: 2053769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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
• Patient Sex: Unknown