MAUDE Adverse Event Report: BIOMET ORTHOPEDICS Q/CONNECT TWIST DRILL 3.2MMX60MM; BIT, DRILL

Model Number N/A

Device Problems Component Falling (1105); Fracture (1260)

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

Event Date 05/14/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial total hip arthroplasty on an unknown date with competitor products.Subsequently, patient was revised on (b)(6) 2015 due to unknown reasons.During the procedure, while the surgeon was implanting the acetabular cup, two drill bits fractured inside the patient and the fractured pieces had to be retrieved.No foreign bodies were retained.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02493).

• Brand Name: Q/CONNECT TWIST DRILL 3.2MMX60MM
• Type of Device: BIT, DRILL
• 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: 4827194
• MDR Text Key: 5840768
• Report Number: 0001825034-2015-02494
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• 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: 31-601114
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention