MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR CROSSLOCK EPAK SCRS & PEGS LOCK SCREW SQ 2.7MM 18MM STE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMIBINATION, MULTIPLE COMPONENT/TRAUMA

Catalog Number	131827118
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.H3: 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
It was reported that there was a foreign substance inside of the sterile packaging of the product.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g2; g3; g6; h1; h2; h3; h6.Visual examination of the returned product and the provided photographs showing there is white debris that is between the clear pouch and the blue sleeve.The device was returned without any shrink film and the tamper label has been cut or torn open.The inner pouch remains sealed and the sterile barrier has not been breached.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet control is considered non-conforming to specification.The root cause of the reported event can be attributed to a manufacturing issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DVR CROSSLOCK EPAK SCRS & PEGS LOCK SCREW SQ 2.7MM 18MM STE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMIBINATION, MULTIPLE COMPONENT/TRAUMA
• 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: 21300113
• Report Number: 0001825034-2025-00249
• Device Sequence Number: 8214067
• Product Code: LXT
• UDI-Device Identifier: 00887868450297
• UDI-Public: (01)00887868450297(17)341111(10)66962842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 131827118
• Device Lot Number: 66962842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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