MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 POSITIONING GUIDE POST; HIP INSTRUMENT

Model Number N/A

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problem No Information (3190)

Event Date 05/09/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Engineer relayed, "based on this investigation and the review of the product, it appears that the part fractured due to a bending overload when the curved acetabular shell inserter was impacted by the surgeon."review of device history records found these units were released to distribution with no deviations or anomalies.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.

Event Description

It was reported that during a hip procedure, the end piece of the g7 rod stuck in the guide post, trapping the guide arm and it fractured.The case was finished with this handle and switched to another one for impacting the liner.

• Brand Name: G7 POSITIONING GUIDE POST
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6903646
• MDR Text Key: 88169907
• Report Number: 0001825034-2017-07583
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003500
• Device Lot Number: ZB130702
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1