MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. COMPONENT KIT; Lavage, Jet

Catalog Number	00515042000
Medical Device Problem Codes	Explosion (4006); Powder Leak (4069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside of surgery when they opened the unit, the battery compartment had exploded and released black dust inside the package.There was no patient harm/injury or surgical delay as there was no patient involvement.Due diligence is complete; 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: france.
Event or Problem Description
There is no additional information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h11.Visual examination of the returned product/provided pictures identified the battery pack was busted open with black debris from battery expulsion throughout the tyvek tray the pack exterior was warped, interior terminals were displaced, batteries were in the correct orientation, and any pre-expulsion wiring damage could not be determined.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Reported event is not related to a combination of products therefore, a compatibility review is not applicable.The root cause is attributed to a manufacturing issue exacerbated by a design issue.The event is 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: COMPONENT KIT
• 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: 22202672
• Report Number: 0001526350-2025-00752
• Device Sequence Number: 7644533
• Product Code: FQH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

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: Health Professional
• Device Catalogue Number: 00515042000
• Device Lot Number: 76896230
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 09/03/2026
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 12/16/2025; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown