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

Model Number	7210707
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ankle procedure, the site of insertion of the twinfix implant was determined and the initiation was performed with the drill 2.8 x 15 mm, it was introduced in the bone and it was not possible to reach the first laser line, the screwdriver suffered torsion and it was not possible to return the implant during this maneuver the suture threads broke, it was tried with other instruments and it was not possible to remove the implant which remained 5 mm outside the bone.Another attempt was made to insert the implant in another new site with a 3.2 drill bit but before reaching the first laser line the screwdriver suffers torsion again it was impossible to insert or remove the implant and again it remained outside the bone, the tissue was tried to cover the implant but it protrudes.The procedure was completed with a one-hour surgical delay using the same device.No further complications were reported.The patient current status is stable.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the suture requirements found that a material certification is required with each lot.A visual inspection of the returned device found that it is not in its original packaging.The grey portion of the handle was not returned.The shaft of the insertion device is warped and bent.The distal end is deformed.There was no anchor or suture material returned.The insertion device has debris on it.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 clinically relevant supporting documentation was provided for inclusion in a medical investigation.The twinfix anchor is implantable, biocompatibility is not an issue.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.Although a one-hour surgical delay was reported it was noted that the patient status was stable no further clinical/medical assessment is warranted at this time.The complaint was of deformation was confirmed, and the root cause was associated with unintended use of the device.The complaint of difficult to insert was not confirmed, and the root cause could not be determined since the reported malfunctions could not be duplicated during the product evaluation process.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, failure to lock the torque limiter, 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: TWNFX TI 3.5 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
• 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: 15234765
• Report Number: 1219602-2022-01169
• Device Sequence Number: 17307213
• Product Code: MBI
• UDI-Device Identifier: 03596010532190
• UDI-Public: 03596010532190
• Combination Product (Y/N): N
• 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,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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 Model Number: 7210707
• Device Catalogue Number: 7210707
• Device Lot Number: 2089219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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