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

Model Number 72200755

Device Problem Break (1069)

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

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that during ankle ligament surgery the anchor fractured, the broken pieces were removed using tweezers.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 part drawing found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A review of the customer provided image found the device with a deployed anchor and sutures in a clear package.No fracture of the anchor can be seen.A visual inspection of the returned device found that it was not returned in its original packaging.The anchor and sutures have been deployed from the device.The anchor is fractured and the threads are deformed.There is debris in the threads of the anchor and on the shaft of the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was 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.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: 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: 12501962
• MDR Text Key: 272427720
• Report Number: 1219602-2021-02069
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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
• Device Operator: Health Professional
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 2052005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 80 KG