MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID SIZER HANDLE; SURGICAL INSTRUMENT HANDLE, NON-TORQUE-LIMITING

Catalog Number	SBGL2000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a primary shoulder surgery, a foreign object was detected on intra-operative radiography before leaving the operating room, and inspection of the sizer handle revealed the push rod was broken.Subsequent inspection confirmed the push rod of the sizer handle had fractured.Attempts have been made and no further information has been provided.
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
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/corrected: a1; b4; b5; d9; g3; g6; h2; h3; h4; h6; h11 complaint sample was evaluated, and the reported event was confirmed.The plunger of the sizer handle has fractured.The fractured piece of the plunger was not returned with the device.Visual examination of the returned product identified signs of use as well as wear and tear.The handle of the device has gouges and knicks on all sides.There are scratches and wear on the body of the sizer as well.The device has a potential field age of 5.5+ years.Measured features of the handle to confirm the device is conforming to print specifications.Fracture analysis has been previously analyzed for this fracture location where overload was identified as the mode of failure.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.

• Brand Name: GLENOID SIZER HANDLE
• Common Device Name: SURGICAL INSTRUMENT HANDLE, NON-TORQUE-LIMITING
• 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: 23879456
• Report Number: 0001822565-2025-04758
• Device Sequence Number: 11930006
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: SBGL2000
• Device Lot Number: 65222906
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male