MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 POSITIONING GUIDE ROD; HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE

Catalog Number	110018822
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the positioning guide rod tip broke while being tightened onto the cup implant.Another guide rod was opened to complete the case.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2.
Event or Problem Description
No further information at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.Visual examination of the provided pictures identified the guide rod has fractured at the tip.There is one fractured off piece shown in the image.There are also wear marks around the shaft of the guide rod.No further observation could be made based on the image alone.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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 POSITIONING GUIDE ROD
• Common Device Name: HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE
• 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: 24069142
• Report Number: 0001825034-2026-00138
• Device Sequence Number: 18486865
• Product Code: OQI
• UDI-Device Identifier: 00887868468742
• UDI-Public: (01)00887868468742(11)240226(10)ZB7711464
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 06/04/2026

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: 110018822
• Device Lot Number: ZB7711464
• Was Device Available for Evaluation?: No
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 06/04/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/20/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown