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

Model Number 72202618

Device Problem Difficult to Insert (1316)

Patient Problem Rupture (2208)

Event Date 06/24/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy, the specialist requested two 5.5 mm titanium anchors, the procedure was started with one (1) twinfix ultra 5.5mm and it was observed that one of the threads of the anchor was outside, the implant was not threading into the cortex of the bone, the specialist decided to introduce the stem back into the anchor and try to turn it to continue threading, but it was not possible, for this reason the second anchor was passed to finish the procedure, but it was necessary to drilled an additional hole.The procedure was successfully completed with non-significant delay.No further complications were reported.The patient´s health condition is stable.

Manufacturer Narrative

H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the assembly procedure found that the the units are visually inspected as the anchors and sutures are loaded.This case reports, one of the threads of the twinfix anchor was reportedly outside the implant and was not threading into the cortex of the bone.Per case details, a second anchor and an additional bone hole was required to successfully complete the procedure.No relevant supporting clinical information including the operative report has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient¿s health condition is reportedly stable, and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided for this complaint will be re-evaluated.The complaint was not confirmed.Factors that could have contributed to the reported event include improper preparation of the insertion site or an application of unintended inappropriate or excessive force to the device.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.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device, anchor and suture materials were returned with biological debris on them, the distal end of the insertion device is bent.The suture material is still attached to both the anchor and the insertion device but the device has been deployed.A functional evaluation could not be performed due to the condition in which the device was received.This device is single-use, therefore, the results of a functional test would be inconclusive.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 complaint history review found no similar reported events.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the assembly procedure found that the units are visually inspected as the anchors and sutures are loaded.The root cause for difficult to insert could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that could have contributed to the reported event include improper preparation of the insertion site or an application of unintended inappropriate or excessive force to the device.The root cause for material deformation was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM TI
• 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: 15253685
• MDR Text Key: 298193661
• Report Number: 1219602-2022-01188
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: 03596010656131
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K100159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202618
• Device Catalogue Number: 72202618
• Device Lot Number: 2085173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2021
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG