MAUDE Adverse Event Report: AVANOS MEDICAL INC. GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS; DH EF PERC PLACEMENT PRODUCTS

Model Number	98701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record and udi number are in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 20-nov-2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint comp (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Event or Problem Description
It was reported two of the "saf-t-pexy t-fasteners broke during a placement procedure." there was no reported injury.Additional information received 30-oct-2024 stated, "the sutures did not loop correctly.".
Additional Manufacturer Narrative
The device history record for the reported lot number, 20126117, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Three loose sutures were received.The product packaging was not returned.The items do not contain a lot number identification.Two of the sutures have the anchor attached, but not the t-bar.The third does not have the anchor or the t-bar.All three had a knot tied approximately 10mm from one end.For the two with the anchors, the knot was at the opposite end from the anchor.On these, there was no portion of suture extending out the other side of the anchor.The overall suture length of these two measures approximately 18cm.The overall length of the one with no anchor measures approximately 16.5cm.The sample provided was evaluated all three have a knot tied approximately 10mm from one end.For the two with the anchors, the knot is at the opposite end from the anchor.On these, there is no portion of suture extending out the other side of the anchor.The overall suture length of these two measures approximately 18cm.Root cause could not be determined.All information reasonably known as of 27-feb-2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20750424
• Report Number: 9611594-2024-00266
• Device Sequence Number: 20878585
• Product Code: KGC
• UDI-Device Identifier: 00350770987019
• UDI-Public: (01)00350770987019(240)109870104(11)240802(17)260529(10)20126117
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 05/29/2026
• Device Model Number: 98701
• Device Catalogue Number: 98701
• Device Lot Number: 20126117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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