MAUDE Adverse Event Report: A&E MEDICAL CORPORATION DW SS #6 14INCCS2 3PK 12PK; METALLIC SUTURE, MONOFILAMENT

Catalog Number	046-267
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire needle fractured while being put though the sternum.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).G2: united kingdom 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of pictures.No product was returned.A visual inspection of the customer provided photo shows that the product has been opened and an attempt was made to use the product.Inspection shows that the needle has fractured.The device history record was reviewed and no discrepancies relevant 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.
Event or Problem Description
Attempts have been made and no further information has been provided.

• Brand Name: DW SS #6 14INCCS2 3PK 12PK
• Common Device Name: METALLIC SUTURE, MONOFILAMENT
• 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: 23051233
• Report Number: 0002242056-2025-00039
• Device Sequence Number: 13271456
• Product Code: GAO
• UDI-Device Identifier: 10841291103790
• UDI-Public: (01)10841291103790(10)28458(17)3000101
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 Catalogue Number: 046-267
• Device Lot Number: 28458
• Was Device Available for Evaluation?: No
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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