MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 3.5 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72200752

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 05/05/2020

Event Type  Injury  

Event Description

It was reported that after surgery, where a twinfix was implanted, the wound presented dehiscence and exudation.This was treated with debridement and local flap transfer during an additional hospitalization.Patient recovered successfully.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h6: one 72200752 twinfix ti 3.5 ultrabraid device used in treatment, was not returned for evaluation.Two complaints were opened.Since two of the same product from different manufacturing lots were used.Due to unavailability, evaluation was limited.Instructions for use provides technique specific instruction.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Breakage of suture anchor can occur if predrilling is not performed prior to implantation.Excessive force during insertion can cause failure of the suture anchor or insertion device.If more torque is required to insert the anchor, stop and ensure that the anchor size, drill hole size, and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the drill hole size to achieve optimal insertion force.It is the responsibility of the surgeon to determine the patient's bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.¿ complaint history review indicated no similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Root cause related to the manufacture of the device was not confirmed.There is no evidence to suggest a direct link between the products used in treatment and the conditions reported.Product met specifications upon release to distribution.

• Brand Name: TWINFIX TI 3.5 ULTRABRAID
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10424787
• MDR Text Key: 203461813
• Report Number: 1219602-2020-01275
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: 72200752
• Device Catalogue Number: 72200752
• Device Lot Number: 2025334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR