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

Catalog Number 72200752

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 07/24/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

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
• Type of Device: 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
• MDR Text Key: 328224194
• Report Number: 1219602-2023-02237
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male