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

Catalog Number 89-8510-440-20

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint number (b)(4).The universal battery for aseptic transfer kit, part number 89-8510-440-20 serial number (b)(4) and lot number 5010650, was returned to the manufacturer.However, the evaluation of the device is not available yet at the date of the report.A follow-up medwatch will be sent when the evaluation is performed.

Event Description

It was reported that the corner of the battery for aseptic transfer kit, part number 89-8510-440-20 serial number (b)(4) and lot number 5010650, melted a little bit.A smell of burning was noticed by the sterilization employee.According to the hospital, this is not due to the fact that the device was in the heater that sterilized the instrument.The battery was unusable.No surgery was involved.There was no harm or impact to the people and environment in the room reported.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Battery for aseptic transfer kit part number 89-8510-440-20 serial number (b)(6) was returned for complaint investigation.Upon receipt, it was confirmed that the battery was melted.There was burn damage on the left side of the device.Besides, the resistors and cells were burnt.The device was not technically repairable.Device was recycled in zimmer geneva premises as per customer instruction.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.

Event Description

It was reported that the corner of the battery for aseptic transfer kit, part number 89-8510-440-20 serial number (b)(6) and lot number 5010650, melted a little bit.A smell of burning was noticed by the sterilization employee.According to the hospital, this is not due to the fact that the device was in the heater that sterilized the instrument.The battery was unusable.No surgery was involved.There was no harm or impact to the people and environment in the room reported.

• Brand Name: UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT
• Type of Device: UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT
• 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: 12370030
• MDR Text Key: 268216343
• Report Number: 0008031000-2021-00036
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8510-440-20
• Device Lot Number: 5010650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other