MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 7210707

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that during the surgery, the technique was being carried out step by step, at the time the suturing started at the second point the twinfix titanium threads got disengaged from the needle, this happened with the white and blue sutures at the 4 ends.The suturing could not be performed.No significant delay or other complications were reported.Smith and nephew twinfix back up device was used to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during a ans/ small joints repair procedure, the technique was being carried out step by step, at the time the suturing started at the second point the twinfix titanium threads got disengaged from the needle, this happened with the white and blue sutures at the 4 ends.The suturing could not be performed.No significant delay or other complications were reported.Smith and nephew twinfix back up device was used into an additional bone hole to complete the surgery.Anchors were left in the patient.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The instructions for use was 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 review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.

• Brand Name: TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10835542
• MDR Text Key: 216095710
• Report Number: 1219602-2020-01836
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010532190
• UDI-Public: 03596010532190
• 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: 04/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 7210707
• Device Catalogue Number: 7210707
• Device Lot Number: 2053678
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 85