MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTO SCR 2.0X7MM 2.0 SYS 2/PK; SCREW, FIXATION

Catalog Number	915-2301
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2, report source, foreign, japan.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 during inspection at the distributorship, it was found that the device had foreign debris within the sterile packaging.There was no patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The reported event was confirmed by review of pictures.Two pieces reported and review of the customer supplied photo shows approximately 5 mm white piece of debris that appears connected at one end and splits in two at opposite end.Follow up with the reporter identified 'looks like a white string inside pouch.' no string is used with the reported product.No product returned.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as packaging process problem.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 further event information is available at the time of this report.

• Brand Name: LACTO SCR 2.0X7MM 2.0 SYS 2/PK
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23742132
• Report Number: 0001032347-2025-00448
• Device Sequence Number: 12876732
• Product Code: HWC
• UDI-Device Identifier: 00841036055028
• UDI-Public: (01)00841036055028(17)290424(10)66743560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971870
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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: Other
• Device Catalogue Number: 915-2301
• Device Lot Number: 66743560
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 03/17/2026; 05/13/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/19/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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