MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. POWER SUPPLY, EU/KR; LAVAGE, JET

Catalog Number	00515035001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that just before check-in to the operating room, the unit was connected and there was heavy smoke development from this motor unit.A condenser (purple-brown large cylinder) had "boiled" or "burned".In the chassis it could be seen the fluid that had come out of the component.There was no patient harm/injury or surgical delay as there was no patient involvement.Due diligence is in process, no further information is available.There was no adverse event associated with this malfunction.
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2 country: sweden.
Event or Problem Description
It was reported that just before check-in to the operating room, the unit was connected to ac outlet and there was heavy smoke development from this motor/power unit and thus not from the flushing nozzle.Smoke was inhaled by staff and patient.A condenser (purple-brown large cylinder) had "boiled" or "burned".In the chassis it could be seen the fluid that had come out of the component.Smoke development occurred before skin cuts, cords were pulled out and the motor unit was locked in an empty pass-through cabinet.After a while, the operation could begin.Due diligence is in process, there is no additional information is available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, g1, g3, g6, h1, h2, h6, and h11.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
There is no additional information regarding the event.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and h11.The pictures provided of the device disassembled were reviewed, however, the photos didn't identify a cause and the product was discarded.No further determinations can be made without product.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.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: POWER SUPPLY, EU/KR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21137950
• Report Number: 0001526350-2025-00048
• Device Sequence Number: 6829686
• Product Code: FQH
• UDI-Device Identifier: 00889024375031
• UDI-Public: (01)00889024375031(11)190531(10)64429441
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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: Health Professional
• Device Catalogue Number: 00515035001
• Device Lot Number: 64429441
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 08/20/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/18/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2019
• 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