MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BICORT DEPTH GAUGE 1.3MM/1.5MM; GAUGE, DEPTH

Catalog Number	231220124
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
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 the tip of a depth gauge broke during screw hole measurement and all fragments were retrieved.During intra-operative measurement of a screw hole, the instrument was withdrawn at an angle, resulting in breakage of the tip of the depth gauge.There were no consequences or impact to the patient.Attempts have been made and no further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: b4; b5; d2; d4; g1; g3; g6; h1; h2; h3; h4; h6.The complaint sample was evaluated, and the reported event was confirmed.The depth gauge tip at the distal end of the device has fractured and was not returned with the device.Visual examination of the returned product identified signs of use with some wear and tear on the knob at the proximal end of the device.Measured the body of the depth gauge, and it conforms to the print.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: BICORT DEPTH GAUGE 1.3MM/1.5MM
• Common Device Name: GAUGE, DEPTH
• 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: 23821237
• Report Number: 0001825034-2025-04007
• Device Sequence Number: 10104775
• Product Code: HTJ
• UDI-Device Identifier: 00887868026898
• UDI-Public: (01)00887868026898(11)171009(10)SC17K001
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/16/2026

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: 231220124
• Device Lot Number: SC17K001
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown