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	Foreign Body In Patient (2687)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ china.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 depth gauge fractured during surgery and there is a foreign body.There are no plans to revise and there has been no known impact of the retained foreign body.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2.The following sections were corrected: d4 lot.The 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 information is available at the time of this report.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product identified nicks and scratches are noted to the distal end and handle from previous uses.Depth gauge is confirmed to be bent and has fractured at the last notch.Fractured piece(s) were not returned for evaluation.No other damage was noted.Device has an approximate field age of 5 years.Fracture analysis has been previously analyzed for this fracture location where bending overload was identified as the mode of failure.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and review of the available records identified the following: the right hip arthroplasty is anatomically aligned.The femoral implant is incompletely visualized.There is a retained metallic implant within the acetabulum consistent with the fractured depth gauge.A definitive root cause cannot be determined.This complaint can be confirmed via the returned product evaluation and x-ray review.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: 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: 21872611
• Report Number: 0001825034-2025-01152
• Device Sequence Number: 15645631
• Product Code: JDI
• UDI-Device Identifier: 00880304569003
• UDI-Public: (01)00880304569003(11)200317(10)067928
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

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: 110010717
• Device Lot Number: 067928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/21/2025; 05/28/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/16/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown