MAUDE Adverse Event Report: ZIMMER SURGICAL SA X-SERIES SAGITTAL SAW ATTACH; SURGICAL POWER TOOL

Catalog Number	89-8522-450-60
Medical Device Problem Codes	Mechanical Problem (1384); Overheating of Device (1437); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: spain.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the adapter loosened from the handpiece during operation, then overheated and stopped working.No consequences or impact to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following section was corrected: d4 primary unique device identification (udi) number.No product was returned.Review of the provided pictures found the attachment and signs of wear; however, product evaluation is needed to determine if the device is overheating and functioning properly.Review of the device history record identified no deviations or anomalies during manufacturing.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.The event cannot be confirmed.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: X-SERIES SAGITTAL SAW ATTACH
• Common Device Name: SURGICAL POWER TOOL
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21110249
• Report Number: 0008031000-2025-00011
• Device Sequence Number: 20692137
• Product Code: GEY
• UDI-Device Identifier: 00889024521322
• UDI-Public: (01)00889024521322(11)220531(10)5016787
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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 Catalogue Number: 89-8522-450-60
• Device Lot Number: 5016787
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown