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

Catalog Number	72200752
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Cartilage damage (4833)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in 2020 a patient had an avulsion fracture of the inferior stop of the acl of the right knee, which was treated with microscopic reduction and internal fixation using a twinfix.On (b)(6) 2023 the patient presented with an articular strangulation and was admitted to the hospital for the removal of the internal fixation.Combined antibiotics were used.Patient recovered well and was discharged from the hospital with good healing.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.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 no 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 clinical review states no relevant supporting clinical information has been provided for inclusion in this medical evaluation.Therefore, a thorough medical investigation could not be rendered, nor could a definitive clinical root cause of the reported adverse event be determined.Nor could the causal relationship between the s&n device and the reported issue cannot be confirmed.The impact to the patient was the articular strangulation, the hospitalization, the second surgery and the medication administration.The future impact would include the recovery period and follow-up office visits.Therefore, no further clinical/medical assessment can be rendered at this time.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.H11: h2: corrected data on: h6 (health effect - clinical code & health effect - impact code).

• 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: 18145013
• Report Number: 1219602-2023-02237
• Device Sequence Number: 6875232
• Product Code: JDR
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152566
• 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
• Report Date (Section B): 02/27/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2024
• Device Catalogue Number: 72200752
• Device Lot Number: 2027478
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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: 34 YR
• Patient Sex: Male