MAUDE Adverse Event Report: SMITH & NEPHEW, INC. XTENDOBUTTON FIXATION DEVICE; RETENTION DEVICE, SUTURE

Catalog Number	72200134
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during set up, the xtendobutton fixation device inner packaging bag had leaked air, the sterile barrier was compromised.There was a back-up device available, and there was a delay of less than 30 minutes.There was no patient involvement.
Additional Manufacturer Narrative
H2: corrected information in h6 (investigation findings & component code).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the packaging of the device opened and it appears to be cut in half.The label with the product's lot number is on the packaging.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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 packaging sequence of endobutton direct, found that the packaging associate must verify pouch is free of pin holes, cuts, particulates and seal defects.Insert the product slowly to minimize pouch surface defects.Inspect s&n seals for creases or wrinkles on the seal.Reject pouch if these defects are found.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 reported event include unintended impact event inconsistent with normal use or improper handling during storage or transportation.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: the reported device was received for evaluation.A visual evaluation showed the xtendobutton was returned in original packaging with the batch number of the complaint on the label.The outer pouch has been torn open.The inner pouch has been cut open on the non-chevron end.The xtendobutton has no visible defect.An image evaluation was performed and found the packaging of the device opened and it appears to be cut in half.The label with the product's lot number is on the packaging.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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 packaging sequence of endobutton direct, found that the packaging associate must verify pouch is free of pin holes, cuts, particulates and seal defects.Insert the product slowly to minimize pouch surface defects.Inspect s&n seals for creases or wrinkles on the seal.Reject pouch if these defects are found.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 reported event include unintended impact event inconsistent with normal use or improper handling during storage or transportation.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: XTENDOBUTTON FIXATION DEVICE
• Common Device Name: RETENTION DEVICE, SUTURE
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22626958
• Report Number: 1219602-2025-01870
• Device Sequence Number: 13030157
• Product Code: KGS
• UDI-Device Identifier: 03596010565471
• UDI-Public: 3596010565471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

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: 72200134
• Device Lot Number: 2142500
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 12/10/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/08/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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