MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR MONOBLOCK SHELL INSRTR; INSTRUMENT HIP

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2014

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.Based on dhr¿s, the product is made to print and correct materials.Product left conforming to print as there is no evidence that states otherwise.Product likely failed due to misuse, by instrument being put through excessive force by tightening trial to inserter too tight, and/or not inspected for wear and disfigurement which may have prevented the use of the instrument and its failure.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues for this lot.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 while the g7 insertion handle was being used during a presentation at the distributor's office, the trial was tightened too tight and now the product cannot be removed.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• Type of Device: INSTRUMENT HIP
• 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: 6908305
• MDR Text Key: 89510186
• Report Number: 0001825034-2017-07694
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2014
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 280310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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