MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR RVS BSPLT RMR 25MM SHORT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110029136
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Visual examination of the returned product identified the product shows signs of heavy repeated use in the form of dull cutting edges with gouges and galling along the shaft of the device.No visible bend in the shaft was noticed.Dimensional analysis of the cannulation identified it was conforming to specification.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported product was confirmed worn through product return.H6: proposed code: mechanical (g04)- drill.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
It was reported that prior to surgery on that the mini baseplate reamer was bent; it was noticed that when the reamer was connected to power and started to spin that is seemed to wobble and the surgeon felt like it must be bent and asked for a replacement.There was no harm, injury, medical/surgical intervention or delay reported.Due diligence complete.No additional information is available.

• Brand Name: COMPR RVS BSPLT RMR 25MM SHORT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 21630925
• Report Number: 0001825034-2025-00744
• Device Sequence Number: 8350157
• Product Code: PHX
• UDI-Device Identifier: 00887868470110
• UDI-Public: (01)00887868470110(11)211215(10)209300
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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 Catalogue Number: 110029136
• Device Lot Number: 209300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• 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: 11/12/2024
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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 Age: 75 YR
• Patient Sex: Male