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

Model Number 89-8510-440-20

Device Problems Degraded (1153); Melted (1385); Device Emits Odor (1425); Overheating of Device (1437); Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2018

Event Type  malfunction  

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 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.

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.

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 Description

No further event information available at the time of this report.

• Brand Name: BATTERY FOR ASEPTIC TRANSFER KIT
• Type of Device: 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
• MDR Text Key: 113167780
• Report Number: 0008031000-2018-00021
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 00889024355156
• UDI-Public: (01)00889024355156(11)170720(10)5010219
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• 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