MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4 PEG MOD GLEN TRIAL SZ 4; SHOULDER GLENOID FOSSA PROSTHESIS TRIAL

Catalog Number	SBGL6044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the peg of the glenoid trial fractured during a procedure.No patient harm was reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h4, h11 once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is 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, g3, g6, h2, h3, h6, h11.Visual examination of the returned product identified that one of the pegs has fractured, where the fragment was not returned.There is damage to the sides, bottom, and articular surface.All of the product identifiers are conforming to the print.Further analysis identified fracture surface artifacts of hackle marks and river lines suggest the overload failure mode.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed through product return.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 is available at the time of this report.

• Brand Name: 4 PEG MOD GLEN TRIAL SZ 4
• Common Device Name: SHOULDER GLENOID FOSSA PROSTHESIS TRIAL
• 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: 22010656
• Report Number: 0001822565-2025-01356
• Device Sequence Number: 20804272
• Product Code: KWS
• UDI-Device Identifier: 00889024574830
• UDI-Public: (01)00889024574830(10)64927028
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• 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,Followup
• Report Date (Section B): 10/02/2025

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: SBGL6044
• Device Lot Number: 64927028
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 09/30/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/21/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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 Sex: Male