MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL OSCILLATING SAW ATTACH; SAW, POWERED, AND ACCESSORIES

Catalog Number	89-8509-450-60
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2.Foreign - russia.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 oscillating saw jams at a certain angle and movement stops.No patient involvement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Review of the most recent repair record determined the rotation check failed.There was damaged to the fork and eccentric bearing.The oscillating system was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and serial combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.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: SAW, POWERED, AND ACCESSORIES
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23298427
• Report Number: 0008031000-2025-00175
• Device Sequence Number: 4786898
• Product Code: HAB
• UDI-Device Identifier: 00889024354913
• UDI-Public: (01)00889024354913(11)220930(10)5017403
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 89-8509-450-60
• Device Lot Number: 5017403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown