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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/05/2016

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

During a total hip arthroplasty the threaded tip of the inserter fractured.The fractured tip migrated behind the shell and was not able to be retrieved, however, the shell was well-fixed and solid.The procedure was completed with another device.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of device records found no evidence of product non-conformance.Review of the device confirmed the reported condition, as the device was found to be fractured.The fracture pattern is consistent with that of bending overload, most likely due to leveraging the shaft during attempts to reposition the cup and multiple off-center and angled impactions.The device was also noted to have evidence of extensive use; however, a conclusive root cause of the event cannot be determined with the available information.There are warnings in the package insert that these types of events can occur.Under warnings, it states, "intraoperative fracture or breaking of instruments has been reported.Surgical instruments are subject to wear with normal usage.Instruments that have experienced extensive use or excessive force are susceptible to fracture.Also, "biomet recommends that all instruments be regularly inspected for wear and disfigurement.".

• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5867093
• MDR Text Key: 51814347
• Report Number: 0001825034-2016-03039
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 421222
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR