MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFF AXIS COMP MINI REAMER MED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	SSI005659
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the surgeon was using the instrument the tip of the instrument fractured.The piece that fractured from tip of the instrument was removed from the patient.There was no harm reported to the patient.
Additional Manufacturer Narrative
(b)(4) h3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.H6: proposed component code: mechanical (g04) - drill.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g2; g3; g6; h1; h2; h3; h6.Visual examination of the returned product identified the reamer returned shows signs of use and wear and tear.There are gouges around the outer surface of the reamer and the post of the reamer has discoloration and some galling.The post has fractured off and was returned with the reamer.The reported part and lot numbers match the numbers etched on the device.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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
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/corrected: b4; b5; d2; g1; g3; g6; h1; h2.Upon reassessment of the reported event, it was determined to be not reportable.There are no same/similar events that would be considered a sentinel event for this particular item and malfunction.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OFF AXIS COMP MINI REAMER MED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 21587453
• Report Number: 0001825034-2025-00688
• Device Sequence Number: 8832836
• Product Code: PHX
• UDI-Device Identifier: 00889024585256
• UDI-Public: (01)00889024585256(11)211207(10)97019964
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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: SSI005659
• Device Lot Number: 97019964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 01/20/2026
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 07/22/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male