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

Model Number	72200146
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem 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
• Common Device Name: 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
• Report Number: 1219602-2023-00978
• Device Sequence Number: 12587758
• Product Code: NBH
• UDI-Device Identifier: 03596010597250
• UDI-Public: 03596010597250
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 02/21/2024; 02/21/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 02/23/2024; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown