MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL OSCILLATING SAW ATTACH; BURRING POWER TOOL ATTACHMENT

Catalog Number	89-8509-450-60
Medical Device Problem Codes	Overheating of Device (1437); Mechanical Jam (2983); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device tip heated up, smoked, and jammed; when it worked, it produced uneven sounds suggesting the element was worn out and seized.On an unknown date, the issue was observed during device use outside of a surgical procedure.The device reportedly overheated, emitted smoke, and intermittently jammed.When functioning, it made uneven sounds, and the reporter suspected internal wear or seizure of the element.No environmental conditions or other contributing factors were reported.There was no patient involvement.No consequences or impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in poland.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, h11.Complaint can be confirmed through the returned product analysis.Review of the most recent repair record determined malfunctioning eccentric system, excentric shaft replaced to solve the reported event.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Root cause has been identified as component failure from repeated use.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: UNIVERSAL OSCILLATING SAW ATTACH
• Common Device Name: BURRING POWER TOOL ATTACHMENT
• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23567817
• Report Number: 0008031000-2025-00195
• Device Sequence Number: 18606602
• Product Code: HAB
• UDI-Device Identifier: 00889024354913
• UDI-Public: (01)00889024354913
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 Catalogue Number: 89-8509-450-60
• Device Lot Number: 5013126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• 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