MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL ASEPTIC TRANSFER KIT HOUSING; SURGICAL POWER TOOL BATTERY-EXCHANGE STERILITY COVER

Catalog Number	89-8510-440-10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery housing returned to the warehouse from the hospital had a lid torn off.No more information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in poland.It was 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Review of the most recent repair record determined: broken hinge.The device was scrapped.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.With given information, 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: SURGICAL POWER TOOL BATTERY-EXCHANGE STERILITY COVER
• 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: 23434221
• Report Number: 0008031000-2025-00183
• Device Sequence Number: 4758466
• Product Code: MOQ
• UDI-Device Identifier: 00889024355149
• UDI-Public: (01)00889024355149(11)180807(10)5011402
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: Other
• Device Catalogue Number: 89-8510-440-10
• Device Lot Number: 5011402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2018
• 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