MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL SAGITTAL SAW ATTACH; SAWING POWER TOOL ATTACHMENT, SAGITTAL

Model Number	N/A
Medical Device Problem Codes	Overheating of Device (1437); Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
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 during surgery the sagittal saw attach overheats and stops working, and until it cools down it cannot be uncoupled from the handpiece.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b4, b5, d9, e2, e3, g3, g6, h1, h2, h3, h4, h6, h11.Review of the most recent repair record identified no repairs/findings related to the reported event.A definitive root cause cannot be determined as there was no problem found.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.The event cannot be confirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: UNIVERSAL SAGITTAL SAW ATTACH
• Common Device Name: SAWING POWER TOOL ATTACHMENT, SAGITTAL
• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20999522
• Report Number: 0008031000-2024-00211
• Device Sequence Number: 12457657
• Product Code: GEY
• UDI-Device Identifier: 00889024521322
• UDI-Public: (01)00889024521322(11)221111(10)5017712
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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 Model Number: N/A
• Device Catalogue Number: 89-8522-450-60
• Device Lot Number: 5017712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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