MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200146
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
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.The procedure was completed with a change in the surgical technique using biosure device fixations of both ends.It is unknown if there was a surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10: 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 process of tendon traction, the button was sucked inside the femoral bone canal before the button flipped.The surgeon and assistant tried to withdraw the button from the channel and tension again several times.Finally, the bone canal cracked and could no longer be fixed with tabs.The procedure was completed with a change in the surgical technique using biosure device fixations of both ends.There was a non-surgical delay and no further complications were reported.
Additional Manufacturer Narrative
Part of the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The green suture and the endobutton were returned without the dtex sling or the white suture.There is biologial debris on the returned items.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the provided photo was reviewed and appears to show an endobutton device.However, it does not aid in determining the root cause of the reported event.The patient impact beyond the reported cannot be determined due to insufficient information.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.

• Brand Name: ENDOBUTTON CL ULTRA 15MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 16612138
• Report Number: 1219602-2023-00416
• Device Sequence Number: 6281045
• Product Code: MBI
• UDI-Device Identifier: 03596010597250
• UDI-Public: 03596010597250
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 2077170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 01/18/2024
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 03/29/2023; 01/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown