MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 STR INSERTER THREADED SHAFT; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 11/04/2016

Event Type  Injury  

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.

Event Description

It was reported that during an operation tip of the inserter threaded shaft was fractured during second impaction.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The following sections were updated: updated name.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Hardness testing was performed and device was found to be conforming.Fracture analysis and material composition analysis were performed by the sem lab.Fracture analysis of the part suggests possible primary overload fracture starting at the lower side and propagated across to the higher fracture surface.Labeling review was performed and noted ¿based on the surgical technique, levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads." 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional/corrected information.Complaint sample was evaluated and the reported event was confirmed through visual inspection.Visual inspection of the inserter showed fractures of the distal threads of instrument.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

Event Description

It was reported that during an operation tip of the inserter threaded shaft was fractured during second impaction.It was unknown if fractured piece fell into patient, but it was noted that all fractured pieces were removed attempts were made to obtain additional information; however, none was available.

• Brand Name: G7 STR INSERTER THREADED SHAFT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6153079
• MDR Text Key: 61702360
• Report Number: 0001825034-2016-05073
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110003452
• Device Lot Number: 410764
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1