MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 20MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200147
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Rupture (2208)
Date of Event	06/08/2022
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 using endobutton, the white suture broke under the strain, the closed-loop of the endobutton was cut because the plates could not be removed.The procedure was successfully completed with a surgical delay of 30 minutes using a back-up device.The plate was removed from the patient and an additional bone hole was required to complete the surgery.No further complications were reported.Current health status is good, patient has been discharged.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10 h3, h6: part of the reported device was received for evaluation.A visual inspection revealed it was received with the white closed suture loop missing from the button.The device was also coated in debris.No physical damage visible to the button.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 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 review of the material specifications found each shipment is accompanied by a certificate of conformance and a lot sample must pass a tensile strength requirement prior to release.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: ENDOBUTTON CL ULTRA 20MM
• 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: 15117867
• Report Number: 1219602-2022-01064
• Device Sequence Number: 5614175
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: 03596010597267
• 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,Consumer,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2026
• Device Model Number: 72200147
• Device Catalogue Number: 72200147
• Device Lot Number: 2070398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2022
• Supplement Date Received by Manufacturer: 02/21/2024; 02/27/2024
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 02/25/2024; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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