MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X58MM SCR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14-405058
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: japan.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that during surgery that it was observed that the device packaging was damaged.There was no harm, injury, surgical/medical intervention to patient and no report of a delay.An alternate product was used to complete the procedure.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d49 g1, g3, g6, h2, h3, h6, h11.Visual evaluation of the provided photos and returned product found the inner sterile pouch is broken into multiple pieces.Sterility is considered not breached.Review of the device history record identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event cannot be determined.This complaint has been confirmed by evaluation of the provided photos and returned product.The device evaluation found that the sterility of the packaging was not breached.The event did not cause of contribute to injury; therefore, this would not be considered a reportable event.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
No additional information is available regarding the incident.

• Brand Name: TI-DBLE LEAD CORT 5.0X58MM SCR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21546258
• Report Number: 0001825034-2025-00591
• Device Sequence Number: 17916970
• Product Code: HSB
• UDI-Device Identifier: 00887868092671
• UDI-Public: (01)00887868092671(17)270417(10)857610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063570
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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 Catalogue Number: 14-405058
• Device Lot Number: 857610
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2017
• 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