MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 STR MONOBLOCK SHELL INSRTR; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

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.There are warnings in the package insert that state that this type of event can occur: under precautions, "intraoperative fracture or breaking of instruments has been reported for general instruments.Device requested, not yet received.

Event Description

During an initial right total hip arthroplasty, the inserter tip fractured.The fractured piece fell in to the shell and did not contact the patient.The fractured piece was removed and the procedure was completed with another inserter without delay.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Failure mode was instrument fracture with the inserter shaft and end strike plate identified with scratches and indentation marks.Scratches & indentation marks were also noted on the handle.The threaded tip on the inserter was also fractured.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5940937
• MDR Text Key: 54395672
• Report Number: 0001825034-2016-03557
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 805760
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/04/2016; 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• 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