MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72200750
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use, the 'twinfix' anchor pulled out post deployment.It is unknown if a backup device was available and how the issue was resolved.There was a non-significant delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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 way to determine if the device contributed to 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 was documented appropriately, and there were no indications to suggest that the anticipated risk region is not adequate.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TWINFIX TI 2.8 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: 13537037
• Report Number: 1219602-2022-00226
• Device Sequence Number: 5325318
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K972326
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 01/06/2026
• Device Model Number: 72200750
• Device Catalogue Number: 72200750
• Device Lot Number: 50914386
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 05/04/2022
• Date Device Manufactured: 01/06/2021
• 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: Required Intervention
• Patient Sex: Unknown