MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINITAC 2.0 DURABRAID; STAPLE, FIXATION, BONE

Model Number 72200795

Device Problem Break (1069)

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

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during achilles tendon surgery, the suture of the minitac broke during suturing.The procedure was successfully completed with non-significant delay using a back-up device.No further complications were reported.

Manufacturer Narrative

H2: additional information ¿a1, a1, a3, a4, b5, h6¿.

Event Description

It was reported that during achilles tendon surgery, the suture of the minitac broke during suturing.The suture was removed by tweezers.The procedure was successfully completed with non-significant delay using a back-up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4) 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 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 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 sutures found that a material certification is required with each lot.A review of the customer provided images found labelling confirming the product identification information.The anchor is still on the distal end of the device, but no sutures are pictured.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 not confirmed.Factors that could have contributed to the reported event include excessive force or torsion during use or use of sharp instruments near the device tip.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

H3, h6: part of the reported device was received for evaluation.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.A review of the sutures found that a material certification is required with each lot.A review of the customer provided images found labelling confirming the product identification information.The anchor is still on the distal end of the device, but no sutures are pictured.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and the handle of the device is severely bent and deformed.No sutures were received.There is debris on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.Per case details the broken suture was removed from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was not confirmed, and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include excessive force or torsion during use or use of sharp instruments near the device tip.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: MINITAC 2.0 DURABRAID
• 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: 13087810
• MDR Text Key: 282777031
• Report Number: 1219602-2021-02775
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010585998
• UDI-Public: 03596010585998
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: 72200795
• Device Catalogue Number: 72200795
• Device Lot Number: 50772774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 75 KG