MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR RVS BSPLT RMR 25MM SHORT; BONE-RESECTION ORTHOPAEDIC REAMER, REUSABLE

Catalog Number	110029136
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H6: mechanical (g04) - drill.Visual examination of the returned product identified signs of use as well as wear and tear.There is damage to the blades of the reamer.There is damage on the connecting feature of the reamer as well.There is galling on the shaft which negates visual confirmation of all etches on the device.There are knicks and scratches on the handle of the device as well.Dimensional analysis where measured was conforming.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Complaint is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a reamer was returned with a different complaint with no information available.Investigation of the reamer determined it was worn.Attempts have been made and no further event information is available at the time of this report.

• Brand Name: COMPR RVS BSPLT RMR 25MM SHORT
• Common Device Name: BONE-RESECTION ORTHOPAEDIC REAMER, REUSABLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24045408
• Report Number: 0001825034-2026-00102
• Device Sequence Number: 13026214
• Product Code: PHX
• UDI-Device Identifier: 00887868470110
• UDI-Public: (01)00887868470110(11)230215(10)65711999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: Other
• Device Catalogue Number: 110029136
• Device Lot Number: 65711999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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