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

Model Number 72200752

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Rupture (2208)

Event Date 08/19/2022

Event Type  Injury  

Event Description

It was reported that, during use, the twinfix anchor fell off the suture when knotting.Surgery was resumed, using a back-up device instead, however, it is unknown if there was any delay.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found 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 review of the titanium found no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A visual inspection of the returned device found that it is not in its original packaging.The insertion device and anchor were returned with no suture material.There is biological debris on the anchor and insertion device.This case reports that the twinfix anchor fell off the suture when knotting and it unknown if all pieces were retrieved from the patient.Based on the information provided no clinical factors were found which would have contributed to the reported event.The twinfix anchor is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause could not be determined.Factors that could have contributed to the reported event include inadvertently pulling the suture through the anchor eyelet during knot tying.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: 15363832
• MDR Text Key: 299310077
• Report Number: 1219602-2022-01316
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

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: 72200752
• Device Catalogue Number: 72200752
• Device Lot Number: 2057215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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): Other