MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 15MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72200146

Device Problem Insufficient Information (3190)

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

Event Date 05/20/2023

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction surgery, when tightening the suture loop of the endobutton, the bone tunnel got damage, in the tendon traction, the bone canal cracked and could no longer fixed with tabs.The procedure was completed using a different surgical technique (compression of biosure device fixations) in the originally drilled hole, with a non-significant surgical delay.After the surgery, no damage was found to the patient and no complications were found.No further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Internal complaint reference case(b)(4).The reported device was received for evaluation.A visual inspection revealed that the device was not in its original packaging.The endobutton was returned without the dtex loop or green suture string.The white suture string was returned.There was debris on the device.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.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an acl reconstruction surgery, when tightening the suture loop of the endobutton, the bone tunnel got damage, in the tendon traction, the bone canal cracked and could no longer fixed with tabs.The procedure was completed using a different surgical technique (compression of biosure device fixations) in the originally drilled hole, with a surgical delay greater than 30min.After the surgery, no damage was found to the patient and no complications were found.No further complications were reported.

• Brand Name: ENDOBUTTON CL ULTRA 15MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 17172900
• MDR Text Key: 317679908
• Report Number: 1219602-2023-00978
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 2077171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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