MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL ASEPTIC TRANSFER KIT HOUSING; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number	89-8510-440-10
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - romania.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the housing can not be closed properly.No consequences or impact to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, e1, e3, g3, g6, h1, h2, h3, h4, h6, h11.The reported event could not be confirmed.Review of the most recent repair record identified no repairs related to the reported event.The locking tests passed.The device history record was not reviewed as this is a limited investigation, a review of manufacturing records, a complaint history review, and a product hold/recall search will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.A definitive root cause cannot be determined.Upon completion of the investigation reassessment was found that the event is not reportable.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 the housing can not be closed properly.No consequences or impact to the patient.Attempts have been made and no further information has been provided.

• Brand Name: UNIVERSAL ASEPTIC TRANSFER KIT HOUSING
• Common Device Name: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23345780
• Report Number: 0008031000-2025-00177
• Device Sequence Number: 15815624
• Product Code: MOQ
• UDI-Device Identifier: 00889024355149
• UDI-Public: (01)00889024355149(11)231222(10)5019828
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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
• Device Catalogue Number: 89-8510-440-10
• Device Lot Number: 5019828
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown