MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL COMPACT BATTERY CHARGER

Catalog Number	89-8510-421-00
Medical Device Problem Codes	Mechanical Problem (1384); Overheating of Device (1437)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information was received that the device will not be returned to the manufacturer.A device history records review was performed for this product part number 89-8510-421-00 serial number (b)(4).No issue was found during the manufacturing process that could explain the defect reported.
Event or Problem Description
It was reported that the compact battery charger, part number 89-8510-421-00 serial number (b)(4), broke down and probably burned out, smoke and sparks appeared.No surgery was involved.There was no harm or impact to the people and environment in the room reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The device was not returned for complaint investigation as documented in the product retrieval task.The device could not be visually inspected in an effort to confirm the defect.No repair has been performed as the product was not returned.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: UNIVERSAL COMPACT BATTERY CHARGER
• Common Device Name: UNIVERSAL COMPACT BATTERY CHARGER
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11306555
• Report Number: 0008031000-2021-00003
• Device Sequence Number: 9134083
• Product Code: MOQ
• UDI-Device Identifier: 00889024355125
• UDI-Public: (01)00889024355125(11)120330(10)5001006
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: 89-8510-421-00
• Device Lot Number: 5001006
• Was Device Available for Evaluation?: No
• 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: 02/02/2021
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2012
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown