MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOS 3.5MM HEX DRIVE; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/05/2015

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.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04438 / 04439).

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6), 2015.During the procedure, the tips of the screw driver and the screw in trial fractured, resulting in a forty-five (45) minute delay.Another screwdriver was used to complete the procedure.No fractured pieces fell into the patient and no implant had to be removed.

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

Examination of returned device found no evidence of product non-conformance.Root cause of the event was most likely attributed to surgical technique; however, a conclusive determination could not be made.

• Brand Name: ARCOS 3.5MM HEX DRIVE
• 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: 5181260
• MDR Text Key: 29380625
• Report Number: 0001825034-2015-04438
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: PK090757
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-301852
• Device Lot Number: ZB141201
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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