MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 STR MONOBLOCK SHELL INSRTR; INSTRUMENT, MANUAL

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿.

Event Description

It was reported that patient underwent a hip arthroplasty on (b)(6) 2015.During the procedure, the surgeon used a mallet to impact the handle on the strike plate.Upon impaction, the threads of the screw hole were damaged.In an attempt to remove the handle, the handle fractured.It is unknown if pieces had to be retrieved from patient.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).This report is being submitted late as it has been identified in remediation.This follow up report is being filed to relay additional and corrected information.The previous medwatch report, mfr 0001825034-2015-04325-1, stated this event was not reportable; however, it was submitted in error and should be disregarded.Complaint sample was evaluated and the reported event was confirmed.Product left conforming to print as there was no evidence that states otherwise.The acetabular inserter¿s screw hole was deformed and the handle had fractured as stated in the complaint.The hole was deformed due to repeated impactor blows.The handle of the inserter most likely fractured due to repeated mallet blows to the side of the handle body which the handle was not designed to withstand.Inspection of the instrument prior to the procedure may have prevented this failure.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under "care and handling of instruments," it states that "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.Care must be taken to avoid compromising their exacting performance." 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 no pieces were retained in the patient.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• Type of Device: INSTRUMENT, MANUAL
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 5156186
• MDR Text Key: 28495032
• Report Number: 0001825034-2015-04325
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 724340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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
• Patient Outcome(s): Required Intervention