MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM TI; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, after drilling with a 3.8 mm drill bit, the device was implanted, when half of the anchor implant was carried, it began to rotate on its axis without visualization of the screw entry, presenting rupture of the suture threads.A reverse extraction screw was used and the implant was extracted.The procedure was completed with a s+n back-up device.No significant delay was reported, and no other complications were reported.Patient's health condition is stable.
Event or Problem Description
It was reported that during an arthroscopy, after drilling with a 3.8 mm drill bit, the device was implanted, when half of the anchor implant was carried, it began to rotate on its axis without visualization of the screw entry, presenting rupture of the suture threads.A reverse extraction screw was used and the implant was extracted.The procedure was completed with a s+n back-up device in the same bone hole.No significant delay was reported, and other complications were reported.Patient's health condition is stable.
Additional Manufacturer Narrative
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 suture materials, found material specifications, lot traceability requirements, that the sutures must be visually inspected for all non-conforming attributes.Each shipment must have a manufacturers certificate of conformance.Fiber tenacity, linear density, knot break strength, and diameter must be certified.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.
Additional Manufacturer Narrative
The reported device was received for evaluation.There was a 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 review of the suture specifications found material specifications, lot traceability requirements, that the sutures must be visually inspected for all non-conforming attributes defined in the procedure and according to the acceptance criteria on the part drawing.Each shipment must have a manufacturers certificate of conformance.Fiber tenacity, linear density, knot break strength, and diameter must be certified.A visual inspection of the returned device found that it is not in its original packaging.The threads of the anchors are bent and deformed from use, and there is debris in the threads.The blue suture is split and frayed in the center.There is a knot tied near the needle of the blue suture.Based on the condition of the product material found during visual inspection, additional material testing is not required.A functional evaluation could not be performed due to the condition in which the device was received.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent 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: TF ULTRA 2 UBRAID AND NDLS 5.5MM TI
• 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: 12297615
• Report Number: 1219602-2021-01681
• Device Sequence Number: 11908580
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: 03596010656131
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2023

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: 03/18/2026
• Device Model Number: 72202618
• Device Catalogue Number: 72202618
• Device Lot Number: 2069003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 02/08/2023
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/09/2021; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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: Male