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

Model Number	7210707
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Foreign zip code: (b)(6).Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a foot procedure, the needles came off from the twinfix anchor while tying the knots and or passing.Also some suture breakage was experienced.It is unknown how the procedure was completed.No significant delay was reported.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: 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 complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A review of the test specification found sample sizes, inspection methods, testing methods, and acceptance criteria for testing needle to suture attachment.The procedure found that a visual inspection must be performed.Based on how the anchor is used, it is not likely that the needles would have been left behind within the patient, but this was not confirmed or communicated so it must be assumed that the needle was left behind.The material has good biocompatibility in a variety of invasive, limited duration contact applications, however this needle is not approved for implantation; therefore, long-term implantation data is not available.If retained the patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.Since there were no patient injuries reported and no apparent patient impact based on the details provided, no further medical assessment is warranted.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• MDR Report Key: 10911442
• Report Number: 1219602-2020-01942
• Device Sequence Number: 3056163
• Product Code: MBI
• UDI-Device Identifier: 03596010532190
• UDI-Public: 03596010532190
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2025
• Device Model Number: 7210707
• Device Catalogue Number: 7210707
• Device Lot Number: 2051981
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 11/04/2021
• Date Device Manufactured: 05/16/2020
• 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; Required Intervention