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

Model Number 98701

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported that one of the suture threads snapped after one day of use.No patient injury.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30146646 was reviewed and the product was produced according to product specifications.All information reasonably known as of 10 mar 2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 complaint database and identified as complaint (b)(4).

• Brand Name: GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS
• Type of Device: 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13732114
• MDR Text Key: 287008176
• Report Number: 9611594-2022-00031
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10680651987010
• UDI-Public: 10680651987010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 98701
• Device Catalogue Number: N/A
• Device Lot Number: 30146646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1