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

Model Number	N/A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a failure of the battery charger occurred causing the batteries to become warm during charging and not fully charge.This event is related to a malfunction that could potentially lead to a serious injury.However, no patient harm or further outcome has been reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Foreign source: poland.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).Upon review of this complaint from an investigation perspective, it is considered that the compact battery charger within this complaint does not impact the reported event of the battery failure.Upon reassessment of the reported event, this report should be voided.Given the above information this medwatch will be voided.
Event or Problem Description
Upon review of this complaint from an investigation perspective, it is considered that the compact battery charger within this complaint does not impact the reported event of the battery failure.Upon reassessment of the reported event, this report should be voided.

• Brand Name: UNIVERSAL COMPACT BATTERY CHARGER
• Common Device Name: EXTERNAL DEVICE BATTERY CHARGER
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 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: 15257180
• Report Number: 0008031000-2022-00025
• Device Sequence Number: 20501448
• Product Code: MOQ
• UDI-Device Identifier: 00889024355125
• UDI-Public: (01)00889024355125(11)190214(10)5012103
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: N/A
• Device Catalogue Number: 89-8510-421-00
• Device Lot Number: 5012103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose