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

Model Number	72200147
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up for an acl reconstruction surgery, once the package of the endobutton device was opened, it was found the aseptic pouch was damaged.A back up device was available to complete the procedure.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).The reported device was received for evaluation.A visual inspection revealed it is not in its original packaging.The poly bag has been opened and is damaged where the seal parted.The device is undamaged, the endobutton, dtex sling and suture strings are in factory configuration.There is some non-biologial debris (fibers) 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 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.A review of the pouch blueprints found that the pouches must be free of nicked or frayed edges, clean and free of foreign particles.A material certification must be supplied with each lot.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include improper transport/storage conditions.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: 16863891
• Report Number: 1219602-2023-00642
• Device Sequence Number: 14807824
• 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,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: 09/06/2026
• Device Model Number: 72200147
• Device Catalogue Number: 72200147
• Device Lot Number: 2078847
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 02/21/2024; 02/21/2024
• Initial Report FDA Received Date: 05/03/2023
• 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: 09/06/2021
• 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: Male