MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINITACTI 2.0 HS STR ANCHR 2 DRBRD NDL; STAPLE, FIXATION, BONE

Model Number	7210303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a finger repair procedure, the minitacti 2.0 screw broke from the rib.Non-significant delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.
Event or Problem Description
It was reported that during a finger repair procedure, the minitacti 2.0 screw broke from the rib.All the pieces were successfully removed by tweezers.Non-significant delay was reported, and the procedure was finished with a smith and nephew back up device, used in the originally drilled bone hole.No void was left in the patient.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found 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 review of the anchor found that the certificate of conformance for raw materials and certificate of conformance is required.A visual inspection of the returned device found that it is not in its original packaging.The insertion device and a piece of fractured ti anchor were returned along with an unopened drill and drill guide.There is debris on the opened items.No suture material was returned.The ti anchor was fractured above the suture window near the distal end.Based on the condition of the product material found during visual inspection, additional material testing is not required.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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: MINITACTI 2.0 HS STR ANCHR 2 DRBRD NDL
• 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: 16457332
• Report Number: 1219602-2023-00286
• Device Sequence Number: 16757876
• Product Code: JDR
• UDI-Device Identifier: 03596010533029
• UDI-Public: 03596010533029
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2023

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: 03/11/2025
• Device Model Number: 7210303
• Device Catalogue Number: 7210303
• Device Lot Number: 2053667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/21/2023; 08/11/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/22/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 48 KG