MAUDE Adverse Event Report: ZIMMER SURGICAL SA X SERIES ASEPTIC BATTERY HOUSING; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number	89-8521-470-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that there is a damaged component of aseptic battery housing.During due diligence and as per the received photos of the product, it appeared that the lid of the housing is broken.No known impact or consequence to the patient.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, d4, g3, g6, h1, h2, h3, h4, h6, h11 the reported event was confirmed by review of pictures.No product was returned; dimensional evaluations could not be performed.With the attached picture the fracture in the hinge can be confirmed.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.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.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.
Event or Problem Description
It was reported that there is a damaged component of aseptic battery housing.During due diligence and as per the received photos of the product, it appeared that the lid of the housing is broken.No known impact or consequence to the patient.Attempts have been made and no further information has been provided.

• Brand Name: X SERIES ASEPTIC BATTERY 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: 24267130
• Report Number: 0008031000-2026-00011
• Device Sequence Number: 18806137
• Product Code: MOQ
• UDI-Device Identifier: 00889024581746
• UDI-Public: (01)00889024581746(11)250627(10)5020311
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care 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: 89-8521-470-40
• Device Lot Number: 5020311
• Was Device Available for Evaluation?: No
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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