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

Model 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	05/30/2018
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 or if additional information is received.
Event or Problem Description
It was reported that the battery for aseptic transfer kit, serial number (b)(4), part number 89-8510-440-20 discharged electrolyte and was degraded.The battery was discovered packaged in a cardboard box in a nurse room with burning smell.There were no other products of the same type nearby.According to the picture provided, the battery is partially melted.No surgery was involved.There was no harm or injury to patient/operator reported.
Additional Manufacturer Narrative
Several attempts were made in effort to retrieve the battery for aseptic transfer kit, part number 89-8510-440-20 and serial number (b)(4), and the customer was not able to return the product for investigation.Therefore, it could not be inspected in an effort to confirm the defect.Device history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.
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, h3, h6, h10.The device has not been returned for evaluation; however, a picture was provided that shows the battery was burnt.Dhr review was performed.Device was 10 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: BATTERY FOR ASEPTIC TRANSFER KIT
• Common Device Name: BATTERY FOR ASEPTIC TRANSFER KIT
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7649787
• Report Number: 0008031000-2018-00021
• Device Sequence Number: 19213370
• Product Code: MOQ
• UDI-Device Identifier: 00889024355156
• UDI-Public: (01)00889024355156(11)170720(10)5010219
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Nurse
• 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 Model Number: 89-8510-440-20
• Device Catalogue Number: 89-8510-440-20
• Device Lot Number: 5010219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 02/02/2023
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/22/2018; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• 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