MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BALL HEX DRVR FOR INSR HNDL; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: 110010246 item name g7 osseoti 4 hole shell 56mm f lot # 66175220; 110003453 item name g7 curved acet shell inserter lot # unknown.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2024-00444; 0001825034 -2024 -00443.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the acetabular inserter would not unscrew from the shell.Upon further attempts to release the shell from the inserter, the ball head hex driver broke off the tip of the device.There was no patient impact, surgical delay or foreign retained body.There is no additional information at the time of this report.

• Brand Name: G7 BALL HEX DRVR FOR INSR HNDL
• Type of Device: 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: 18933147
• MDR Text Key: 338025683
• Report Number: 0001825034-2024-00762
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010002736
• Device Lot Number: ZB131201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Sex: Prefer Not To Disclose