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

Catalog Number	89-8521-470-40
Medical Device Problem Codes	Structural Problem (2506); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in slovakia.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 the battery housing could not be closed properly.No patient involvement.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• 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: 24481502
• Report Number: 0008031000-2026-00017
• Device Sequence Number: 13331395
• Product Code: MOQ
• UDI-Device Identifier: 00889024581746
• UDI-Public: (01)00889024581746(11)230526(10)5018636
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 5018636
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown