MAUDE Adverse Event Report: ZIMMER SURGICAL SA X-SERIES STERILIZABLE BATTERY; SURGICAL POWER TOOL

Model Number	N/A
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Upon receipt, the battery gave error code 85 and had no power due to overheat.A definitive root cause cannot be determined.Device is used for treatment.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
It was reported that the battery won't charge.Upon further evaluation, it was found this battery gave error code 85 and had no power due to overheat.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, no patient harm or further outcome was reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Upon review of our reporting decisions overheating or error codes for sterilizable batteries will be updated to be not reportable.A review of all complaints for this product indicates that there has never been an event that has resulted in a death or serious injury nor is the malfunction likely to lead to a death or serious injury.Therefore, zimmer biomet will not be reporting this failure mode going forward.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: X-SERIES STERILIZABLE BATTERY
• Common Device Name: SURGICAL POWER TOOL
• 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: 18757738
• Report Number: 0008031000-2024-00066
• Device Sequence Number: 17076025
• Product Code: MOQ
• UDI-Device Identifier: 00889024581722
• UDI-Public: (01)00889024581722(11)210616(10)202106
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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
• Device Model Number: N/A
• Device Catalogue Number: 89-8521-470-20
• Device Lot Number: 202106
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2023
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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