MAUDE Adverse Event Report: ARTHROCARE CORPORATION ENTACT SEPTAL STAPLER 3-PACK; SEPTAL STAPLER/ABSORBABLE STAPLES

Catalog Number	601-00100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in original packaging.The blue indicator is not to the distal tip indicating a staple is available.Bio debris is present.No visible deficiencies.A functional evaluation showed pulling the trigger closes the upper and lower arms close and an audible click is heard then as the trigger is released, the arms reopen.Fragments of a partial staple were ejected from the device.The blue indicator moved to the distal tip indicating no more staples.A material characteristics assessment found the implant is biocompatible and biodegradable.A desiccant is included in the package of the device to maintain integrity of the implants.Per the ifu the implants are designed to resorb in about 3 to 6 weeks following the degradation principle of hydrolysis.Due to the fact that the returned device was received a month after the occurrence date it cannot be ruled out that fractured staple that was found during the functional evaluation was caused by the expected material degradation of an unsealed product.Therefore, the found fractured implant cannot be used to determine the cause of the original reported failure.An evaluation of the image provided by the customer found a staple broken into two pieces.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 material specifications found that tensile strength requirements are specified and that each lot should be accompanied with a certificate of compliance.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include excessive force on the device or an inadvertent impact event inconsistent with normal use.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during a nasal septum surgery, the entact septal stapler absorbable nail was fractured after deployment and could not be implanted.All the pieces were removed from the patient with suction.Surgery was completed with a back-up device instead.There was no surgical delay, and no further complications were reported.
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.

• Brand Name: ENTACT SEPTAL STAPLER 3-PACK
• Common Device Name: SEPTAL STAPLER/ABSORBABLE STAPLES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21191716
• Report Number: 3006524618-2025-00019
• Device Sequence Number: 3441887
• Product Code: OLL
• UDI-Device Identifier: 00817470006452
• UDI-Public: 817470006452
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082750
• 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): 03/25/2025

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: 601-00100
• Device Lot Number: G23A11566
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• 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