MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 STR MODULAR SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2016

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 the 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 warnings, it states, "the surgeon is to be familiar with the equipment, instruments and surgical procedure prior to performing surgery.".

Event Description

During a hip arthroplasty it was not possible to insert the inner bar into the reamer instrument.It is not known what was used to complete the procedure.There was no patient injury or delay in the procedure.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Review of the device could not confirm the reported condition.A conclusive root cause of the event could not be determined.

• Brand Name: G7 STR MODULAR SHELL INSERTER
• 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: 5907566
• MDR Text Key: 53279834
• Report Number: 0001825034-2016-03309
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/12/2016

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: 110003451
• Device Lot Number: 545550
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1