MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENDON ANCHORS 8; STAPLE, IMPLANTABLE

Catalog Number	2504-1
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up, a tendon anchor puck was not vacuum sealed.There was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is in its original unopened packaging, the device is not vacuum packed, it is sealed but air is in the outer package; the package has channeling in the seal.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 packaging process, found that the sealing operator must ensure that the foil pouch is correctly inserted into the heated sealer bars.It includes the instructions on how to hold the pouch to ensure the correct sealing.The sealing operator must ensure that a vacuum is present, confirming the presence of seals on all edges of the pouch and confirm the s&n seal is on the chevron end of the pouch.Although a review of device records showed there were no indications to suggest that the product did not meet specification upon release for distribution at the time of manufacturing, the root cause of the reported event has been traced to a manufacturing deficiency.Based on this investigation, a corrective was initiated to address the reported failure.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).The reported device was received for evaluation.A visual inspection of the returned device found that it is in its original unopened packaging, the device is not vacuum packed, it is sealed but air is in the outer package; the package has channeling in the seal.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 packaging process, found that the sealing operator must ensure that the foil pouch is correctly inserted into the heated sealer bars.It includes the instructions on how to hold the pouch to ensure the correct sealing.The sealing operator must ensure that a vacuum is present, confirming the presence of seals on all edges of the pouch and confirm the s&n seal is on the chevron end of the pouch.Although a review of device records showed there were no indications to suggest that the product did not meet specification upon release for distribution at the time of manufacturing, the root cause of the reported event has been traced to a manufacturing deficiency.Based on this investigation, a corrective actions and field action was initiated to address the reported failure and recall the product.
Additional Manufacturer Narrative
Section h7 was updated.Section h10: the regeneten tendon anchors have been reported to have a breach in the foil pouch which could potentially compromise the sterility of the product.Due to the potential risk of a biologic response, such as infection due contamination of the sterile field, and to ensure safety, s+n is proactively addressing this issue by reporting it as a class ii recall in accordance with the relevant regulations (fda correction/removal reporting number is not available yet).Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection of the returned device found that it is in its original unopened packaging, the device is not vacuum packed, it is sealed but air is in the outer package; the package has channeling in the seal.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 packaging process, found that the sealing operator must ensure that the foil pouch is correctly inserted into the heated sealer bars.It includes the instructions on how to hold the pouch to ensure the correct sealing.The sealing operator must ensure that a vacuum is present, confirming the presence of seals on all edges of the pouch and confirm the s&n seal is on the chevron end of the pouch.Although a review of device records showed there were no indications to suggest that the product did not meet specifications upon release for distribution at the time of manufacturing, the root cause of the reported event has been traced to a manufacturing deficiency.Based on this investigation, a corrective action and a field action were initiated to address the reported failure and recall the product.

• Brand Name: TENDON ANCHORS 8
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19747434
• Report Number: 3003604053-2024-00033
• Device Sequence Number: 6532685
• Product Code: GDW
• UDI-Device Identifier: 00854501006067
• UDI-Public: 00854501006067
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/20/2024

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: 2504-1
• Device Lot Number: 51180058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 08/13/2024; 08/12/2024; 09/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/08/2024; 08/14/2024; 08/28/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2023
• 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