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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the oscillating saw has stopped working.No patient involvement.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.
Event or Problem Description
It was reported that the oscillating saw has stopped working.No patient involvement.No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; d9; g3; h2; h4; h6 review of the most recent repair record identified the following related repair: malfunctioning excentric system, malfunctioning locking system, excentric shaft replaced and locking mechanism cleaned, device repaired and returned.Review of the previous repair record identified no related repairs to the reported event.The device was tested and found to be functioning to specifications prior to release to the customer.Review of complaint history found no additional related issues for this item and the reported part and serial combination.A definitive root cause cannot be determined.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: 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 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25072986
• Report Number: 0008031000-2026-00032
• Device Sequence Number: 10738603
• Product Code: HAB
• UDI-Device Identifier: 00889024354913
• UDI-Public: (01)00889024354913(11)170403(10)5009651
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 5009651
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2017
• 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