MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210708
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an arthroscopy, after introduce the anchor of the twinfix (when retrieving the threads with needles), 3 threads out of 4 became loose right away.The anchor was left in place in the patient.The procedure was completed with the same device.It is unknown if there was a delay.No other complications were reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A visual inspection of the returned device found that it was not returned in its original packaging.The device was not returned with the anchor or sutures.There are two curved needles in a cup with the device.The shaft of the device shows signs of use.The loose needles have debris on them.The needles do not show signs of damage and the crimps where the suture attached are intact.A functional evaluation could not be performed due to the condition in which the device was received.The complaint was confirmed.Factors that could have contributed to the reported event include the use of excessive force on the device or an impact event inconsistent with normal use.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: TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11853295
• Report Number: 1219602-2021-01180
• Device Sequence Number: 4662945
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: 03596010532206
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: 7210708
• Device Catalogue Number: 7210708
• Device Lot Number: 50876180
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1