MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DEPTH GAUGE; INSTRUMENT, HIP

Catalog Number	110010717
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the depth gauge tip broke.The scrub technician noticed that the depth gauge tip was missing upon opening trays for surgery.This was noted on the back table and was not used on a patient.A back up instrument was not needed.There was no patient impact, no surgical delay, no foreign body retained, and no medical/surgical interventions.It was reported that no further information is available.
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; d4; d9; g3; h2; h3; h6.Product has been received by zimmer biomet and the investigation is in process.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;d4;g3;h2;h3;h4;h6.Product was returned and evaluated.Visual examination of the returned product identified device showed wear from previous uses.Damage included nicks and scratches around the handle and distal tip.The distal end of the depth gauge was fractured at the fifth notch and fractured piece(s) were not returned.Dimensional analysis of the product determined that the product, where measured, conformed to product specifications.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event was not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.The issue was confirmed; however, a definitive root cause cannot be determined.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: G7 DEPTH GAUGE
• Common Device Name: INSTRUMENT, HIP
• 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: 22727290
• Report Number: 0001825034-2025-02380
• Device Sequence Number: 9050999
• Product Code: JDI
• UDI-Device Identifier: 00887868465888
• UDI-Public: (01)00887868465888(11)190610(10)061294
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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: 110010717
• Device Lot Number: 061294
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 12/22/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/13/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• 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: Unknown