MAUDE Adverse Event Report: A&E MEDICAL CORPORATION SS SUT KIT 3DW6 3SW6 12PK; SUTURE, NONABSORBABLE

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the wire packaging's sterility was compromised due to open packaging.There was no patient injury as a result of the malfunction.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: foreign source: singapore customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Returned product was visually evaluated and it was determined that the two pouches are open and were not sealed during manufacturing.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a packaging not sealed during manufacturing.The reported event is confirmed, based on product return and evaluation determining product not sealed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h4, h6, h10 and h11.

• Brand Name: SS SUT KIT 3DW6 3SW6 12PK
• Common Device Name: SUTURE, NONABSORBABLE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20381897
• Report Number: 0002242056-2024-00024
• Device Sequence Number: 6416115
• Product Code: GAO
• UDI-Device Identifier: 10841291101635
• UDI-Public: (01)10841291101635(10)04867(17)270101
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K932513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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 Model Number: N/A
• Device Catalogue Number: 040-355
• Device Lot Number: 04867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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