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

Model Number 72200752

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during procedure, the screw of the twinfix backed off antes implantation.Procedure was completed, after a non-significant delay, with a back-up device.No further complications were reported.

Event Description

It was reported that, during shoulder cuff repair surgery, the screw of the twinfix backed off after implantation.The anchor was removed from the patient using tweezers.Procedure was completed, after a non-significant delay, with a back-up device.No further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 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 visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and there is debris on the device.There are no signs of damage or deficiencies on the device.A functional evaluation could not be performed due to the condition in which the device was received.A review of the customer provided image found the anchor with sutures.No damage or deficiencies can be seen.The complaint was not confirmed, and the root cause could not be determined.Factors that could have contributed to the reported event include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• 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
• 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: 12733623
• MDR Text Key: 279578054
• Report Number: 1219602-2021-02397
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200752
• Device Catalogue Number: 72200752
• Device Lot Number: 2049578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 75 KG