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

Catalog Number	72200147
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an unknown procedure, when opening the packaging of the endobutton ultra, the nurse noticed that the packaging had a hole in it.The same problem was found on a second packaging.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
Health effect - impact code updated.H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device was returned with packaging that has been very roughly handled.There are very small tears, circled in blue ink on both the inner and outer poly packs.The dtex sling has been disturbed from it's original condition.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.A review of the device packaging assembly found that found that the packaging associate must verify that pouch is free of pin holes, cuts, particulates, and supplier seal defects.The root cause has been associated with inappropriate transport or storage.Factors that could have contributed to the reported event include rough shipping and handling, an inadvertent impact event, or excessive shaking in transport.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: 18731387
• Report Number: 1219602-2024-00303
• Device Sequence Number: 6350484
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: 03596010597267
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/10/2024

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 Catalogue Number: 72200147
• Device Lot Number: 2123714
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• 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