MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number 72200755

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a tricep repair procedure, the twixfix suture anchor stripped out while being implanted and had to be removed.The procedure was completed using a back-up device in the originally drilled bone hole.It is unknown if there was a surgical delay.No further complications were reported.

Manufacturer Narrative

H10: 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 way to determine if the device contributed to 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.This case reports, the suture anchor stripped out during implantation and reportedly required removal.The provided e-mail communication titled operative procedure in detail, does not support the reported failure mode which is the twixfix suture anchor stripped out while being implanted and had to be removed.It notes that a total of two 5 mm suture anchors, smith and nephew suture anchors were utilized and their position was confirmed under mini-c-arm fluoroscopy to be safe and appropriate position extraarticular.Once both suture anchors were appropriately tied down and the olecranon and triceps insertion were tightly apposed to each other, i then proceeded to use a 2-0 vicryl suture to repair fascia and soft tissue.The information provided via e-mail does not support or reference the reported suture anchor stripped out while being implanted.No patient injuries or adverse consequences were reported.It was noted via e-mail that the patient met all discharge criteria.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• 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: 14782849
• MDR Text Key: 294602754
• Report Number: 1219602-2022-00908
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 2038292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Date Device Manufactured: 08/01/2019
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 129 KG