MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AUGMENT REAMER DRIVER; ORTHOPAEDIC BALL SPIKE

Catalog Number	SBGL3701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ball hex reamer driver was fractured during a procedure.No patient impact was reported.Attempts have been made and no further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: canada.Visual examination of the returned product identified the driver shows signs of use as well as wear and tear.There are scratches and knicks on the connecting feature.The shaft of the device also has scratches from use.The ball tip has fractured from the shaft of the driver.All pieces were returned.The features of the fracture surface visually align with a torsional overload fracture 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.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.

• Brand Name: AUGMENT REAMER DRIVER
• Common Device Name: ORTHOPAEDIC BALL SPIKE
• 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: 24743094
• Report Number: 0001822565-2026-01010
• Device Sequence Number: 9377093
• Product Code: KWS
• UDI-Device Identifier: 00889024575202
• UDI-Public: (01)00889024575202(10)65053026
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: SBGL3701
• Device Lot Number: 65053026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• 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: 09/18/2025
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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: Unknown