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

Model Number	72200752
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional 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
• Common Device Name: 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
• Report Number: 1219602-2022-01316
• Device Sequence Number: 15192652
• Product Code: MBI
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown