MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 2.5 MM FEMALE HEX SCREW 25 MM LENGTH; INSTRUMENT, KNEE

Catalog Number	42509902525
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	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- japan.H3- customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a pink foreign object had been found inside the plastic bag that contained the sterile screws.It was discovered immediately after opening the bag.There is no additional information available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, and h11 corrected: h4 visual evaluation of the provided photos and returned product found a piece of pink, foreign debris.The debris is not acceptable to inspection criteria zwi 43.098.Analytical testing on the debris found the debris is consistent with silicone adhesive.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported event can be attributed to a manufacturing issue.This complaint is confirmed by review of the provided photos and returned product.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA 2.5 MM FEMALE HEX SCREW 25 MM LENGTH
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21935095
• Report Number: 0001822565-2025-01198
• Device Sequence Number: 5342885
• Product Code: HWD
• UDI-Device Identifier: 00889024232532
• UDI-Public: (01)00889024232532(17)350214(10)67040864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 09/18/2025

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: 42509902525
• Device Lot Number: 67040864
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• 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