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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- foreign- spain.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 lid of aseptic transfer kit housing is broken.No consequences or impact to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, h11.Complaint can be confirmed through the returned product analysis.Review of the most recent repair record determined broken hinge unit scrapped.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.A definitive root cause cannot be determined.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.

• 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 CH-12 28; SZ CH-1228
• 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: 23448618
• Report Number: 0008031000-2025-00188
• Device Sequence Number: 12780955
• Product Code: MOQ
• UDI-Device Identifier: 00889024355149
• UDI-Public: (01)00889024355149(11)230810(10)5019157
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 5019157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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