MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB1.5MM20HOLESTRPLATE; PLATE, FIXATION, BONE

Catalog Number	915-2419
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	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign, event occurred in china.The 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 neurosurgery, noticeable indentations and yellow foreign material were found on the inner sterile packaging.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The reported event could not be confirmed due to a lack of product return.A visual inspection was conducted on the provided photos.The seal and the foil pouch look to be intact.An unidentified substance is visible just below the seal.It cannot be determined what the substance is from the photo.The device history record was reviewed, and no discrepancies relevant to the reported event were found.Root cause has been identified as a manufacturing issue.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
It was reported that during neurosurgery, noticeable indentations and yellow foreign material were observed on the inner sterile packaging, and a backup device was used to complete the procedure.The issue was identified intra-operatively upon opening the sterile package, and the affected device was not used.The patient had no consequences or impact.Attempts have been made and no further information has been provided.

• Brand Name: LACTOSORB1.5MM20HOLESTRPLATE
• Common Device Name: PLATE, FIXATION, BONE
• 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: 23957606
• Report Number: 0001032347-2026-00007
• Device Sequence Number: 9611132
• Product Code: HRS
• UDI-Device Identifier: 00841036055554
• UDI-Public: (01)00841036055554(17)270527(10)428150
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 04/01/2026

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: 915-2419
• Device Lot Number: 428150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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