MAUDE Adverse Event Report: A&E MEDICAL CORPORATION SW #6 30IN CCS3 2PK; SUTURE, NONABSORBABLE

Catalog Number	046-181
Medical Device Problem Codes	Fracture (1260); Material Too Soft/Flexible (4007)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while the surgeon was trying to close the patient's chest using the sternal wire that the surgeon noticed that the sternal wire needle was broken.He mentioned that the sternal wire is too soft or brittle to be used in closing the chest.
Additional Manufacturer Narrative
Complaint (b)(4).G2: foreign source: uk.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: d4, e1, e2, e3, h1, h2, h3, h4, h6 and h11 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported event is unconfirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SW #6 30IN CCS3 2PK
• 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: 22045096
• Report Number: 0002242056-2025-00015
• Device Sequence Number: 18362857
• Product Code: GAO
• UDI-Device Identifier: 10841291103684
• UDI-Public: (01)10841291103684(10)25844(17)290501
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 046-181
• Device Lot Number: 25844
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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