MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL BATTERY FOR ASEPTIC TRANSFERT KIT

Catalog Number	89-8510-440-20
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed.
Event or Problem Description
It was reported that after about 20 minutes of charging on compact battery charger serial number (b)(4), the battery for aseptic transfer kit serial number (b)(4), part number 89-8510-440-20 heated.The staff saw that the battery was starting to produce smoke and switched off the battery charger.According to pictures provided by the customer, a part of the housing melted.No surgery was involved.There was no harm or injury to patient/operator reported.
Additional Manufacturer Narrative
Battery for aseptic transfer kit, part number 89-8510-440-20 serial number (b)(4) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the battery is burnt.The battery management circuit was found to be defective.The battery was disassembled and three cells out of five were defective.The battery is not repairable.It will be recycled in (b)(6).The compact battery charger part number 89-8510-421-00 serial number (b)(4) used with this device was found to be defective.The failure found was three defective led.No link was established with the event reported on the battery, serial number (b)(4).
Event or Problem Description
It was reported that after about 20 minutes of charging on compact battery charger serial number (b)(4), the battery for aseptic transfer kit serial number (b)(4), part number 89-8510-440-20 heated.The staff saw that the battery was starting to produce smoke and switched off the battery charger.According to pictures provided by the customer, a part of the housing melted.No surgery was unvolved.There was no harm or injury to patient/operator reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d8, g3, g6, h1, h2, h6, h10.Upon receipt, the battery was confirmed to be burnt and the battery management circuit was malfunctioning.The battery was scrapped.Dhr review was performed.Device was 25 months old and is not out of box failure.Device is used for treatment.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: UNIVERSAL BATTERY FOR ASEPTIC TRANSFERT KIT
• Common Device Name: UNIVERSAL BATTERY FOR ASEPTIC TRANSFERT KIT
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7220945
• Report Number: 0008031000-2018-00003
• Device Sequence Number: 13742732
• Product Code: MOQ
• UDI-Device Identifier: 00889024355156
• UDI-Public: (01)00889024355156(11)151204(10)5007472
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 02/03/2023

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: 89-8510-440-20
• Device Lot Number: 5007472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 03/15/2018; 02/02/2023
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/27/2018; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2015
• 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