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

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a osteosynthesis peroneus distal + ligamentography , osteosynthesis was performed without complications and the twinfix anchor was positioned, the specialist impacted the tip of the anchor and introduced it turning it around, at the moment of the passage the distal part of the handle of the anchor was bent in great part avoiding that the anchor entered completely.The specialist tried to withdraw the anchor and it was not possible to be withdrawn, it was necessary to pass a cutter to be able to cut the half of the anchor that was left on the outside.A second anchor was passed and the same thing happened, the handle of the anchor twisted in its distal part, the specialist decided to remove the handle and impacted the implant, however the anchor remained a little outside.The procedure was successfully completed with a delay greater than 30 minutes using a back-up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned devices found that they are not in their original packaging.Two insertion devices were returned with no anchors, sutures, needles, needle holders or the assembly shaft.Device 1 has the distal end fractured and twisted, the entire shaft is offset and the end is completely open.Device 2 has the distal end deformed and the shaft is twisted, the entire shaft is offset but intact.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 material specifications found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A clinical review states the provided photo was reviewed but does not aid in the clinical investigation of the root cause of the reported events.Based on the limited information provided, we are unable to rule out a user vs procedural variance as a contributing factor to the reported event.The patient impact beyond that which has been reported cannot be determined.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The root cause has been 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.No containment or corrective actions are recommended at this time.

• Brand Name: TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
• 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: 16112667
• MDR Text Key: 306803592
• Report Number: 1219602-2023-00033
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010532190
• UDI-Public: 03596010532190
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210707
• Device Catalogue Number: 7210707
• Device Lot Number: 2097471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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
• Patient Sex: Male