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

Model Number	N/A
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery did not provide power due to a state of health and overheat issue.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
(b)(4).Dhr review was performed.Device was 27 months old and is not out of box failure.Review of the device history record identified no anomalies during manufacturing related to the reported event.Upon receipt, the battery did not provide power due to state of health issue and 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.

• Brand Name: 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: 18632164
• Report Number: 0008031000-2024-00043
• Device Sequence Number: 7725559
• Product Code: MOQ
• UDI-Device Identifier: 00889024581722
• UDI-Public: (01)00889024581722(11)210622(10)202106
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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