MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 3.5 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72200752
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 patella dislocation repair procedure, the twinfix screw broke from the rib.It is unknown if it occurred inside or outside of the patient.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 patella dislocation repair procedure, the twinfix screw broke from the rib.All the broken 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
The reported device was received for evaluation.A visual inspection revealed the device is not in its original packaging.The insertion device, anchor and suture strings were returned.The ti anchor and suture strings are intact with no fracturing visible under magnification.There is debris on all returned items.Based on the condition of the product material found during visual inspection, no fracture of the implant could be confirmed.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 review of the material specifications found that no burrs, cracks, or contamination is allowed and a certification of compliance to material and processing specifications is required.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 an application of unintended inappropriate or excessive force to 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.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX TI 3.5 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: 16456983
• Report Number: 1219602-2023-00287
• Device Sequence Number: 6515078
• Product Code: JDR
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2023

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: 02/05/2026
• Device Model Number: 72200752
• Device Catalogue Number: 72200752
• Device Lot Number: 2067711
• 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; 07/03/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/22/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 63 KG