MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR AUG OFF-AXIS REAM GDE SM; ORTHOPAEDIC REAMER GUIDE

Catalog Number	110040240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 during shoulder surgery the anterior portion of the glenoid fractured when the reamer blade interacted with a disposable off-axis reamer guide.During intra-operative reaming, the blade dug into the plastic of the guide, which torqued the glenoid and resulted in an anterior glenoid fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, g3, g6, h2, h11.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: COMPR AUG OFF-AXIS REAM GDE SM
• Common Device Name: ORTHOPAEDIC REAMER GUIDE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24152002
• Report Number: 0001822565-2026-00223
• Device Sequence Number: 18384937
• Product Code: PHX
• UDI-Device Identifier: 00889024681965
• UDI-Public: (01)00889024681965(17)350601(10)099457
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110040240
• Device Lot Number: 099457
• Was Device Available for Evaluation?: No
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK REAMER CAT# LOT#.
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Male