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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the minitac anchor was pulled out after the implantation.The procedure was completed using a competitor device.It is unknown if there was a delay and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it is not in its original packaging.The insertion device was returned with the anchor off the device but held in place with the suture strings through the window in the distal end of the shaft.The needles are on the sutures and the sutures, anchor and needles are in a knotted tangle.No biological debris is visible.A functional evaluation could not be performed due to the condition in which the device was received.These findings are related to the reported event.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.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 root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H11: corrected information in h6 (health effect - impact 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: 18486526
• Report Number: 1219602-2024-00085
• Device Sequence Number: 19716160
• 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,Followup
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72202019
• Device Lot Number: 2086810
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 02/29/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/01/2024; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Patient Sex: Unknown