MAUDE Adverse Event Report: CELESTICA VALENCIA SAU HAMMR

Catalog Number	110046298
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Celestica is submitting this report to comply with fda reporting obligations under 21 cfr, part 803.This report is based upon information obtained by celestica, which celestica may not have been able to fully investigate or verify prior to the date the report was required by the fda.Celestica has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, celestica, or its employees that the device, celestica, or its employees caused or contributed to the event described in the report.The device was used for treatment, not diagnosis.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.As of this date, the device has not been received for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Once the investigation is completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.
Event or Problem Description
It was reported that the impactor device was leaking water.This event occurred during surgery and the patient was involved.There were no reports of injuries, medical intervention or prolonged hospitalization.It was reported that the patient did not develop an infection after the surgery, and no medications were administered due to this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: HAMMR
• Common Device Name: HAMMR
• Manufacturer (Section D): CELESTICA VALENCIA SAU; carretera valencia-ademuz; km 17,6; pobla de vallbona, valencia 46185 ; SP 46185
• Manufacturer (Section G): CELESTICA VALENCIA SAU; carretera valencia-ademuz; km 17,6; pobla de vallbona, valencia 46185 ; SP 46185
• Manufacturer Contact: gonzalo encinas ; carretera valencia-ademuz; km 17,6; pobla de vallbona, valencia 46185 ; SP 46185
• MDR Report Key: 21585243
• Report Number: 3010849408-2025-00001
• Device Sequence Number: 15677563
• Product Code: GEY
• UDI-Device Identifier: 08437025586004
• UDI-Public: 08437025586004
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: 110046298
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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 Age: 76 YR
• Patient Sex: Female