MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72200755

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 05/04/2019

Event Type  Injury  

Event Description

It was reported that one month after repair of medial collateral ligament, the patient experienced swelling and infection.Incision, drainage and irrigation were performed in order to treat the adverse event.The patient was discharged from the hospital.No other complication were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One twinfix ti 5.0 ultrabraid device used in treatment, was not returned for evaluation.Evaluation was limited without product.Review indicated no similar allegation for the lot number reported.Batch review did not indicate condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.No additional actions required.Relationship between the event and device was unconfirmed.Per clinical/mi: no relevant clinical information is provided, recommend closure.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10525938
• MDR Text Key: 206718047
• Report Number: 1219602-2020-01391
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 50728744
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR