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

Catalog Number 89-8510-421-00

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

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 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.

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 Description

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

• Brand Name: UNIVERSAL COMPACT BATTERY CHARGER
• Type of Device: 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
• MDR Text Key: 231114173
• Report Number: 0008031000-2021-00003
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 00889024355125
• UDI-Public: (01)00889024355125(11)120330(10)5001006
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2012
• 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