MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN GUIDE WIRE; FIXATION, FASTENER

Model Number N/A

Device Problems Fracture (1260); Sticking (1597); Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/18/2014

Event Type  Injury  

Event Description

It was reported that patient a underwent bunionectomy on (b)(6) 2014.During the procedure the screw driver stripped out the head of one screw and the screw was not able to progress any further.Surgeon implanted a second screw and a guide wire fractured off twice in the screw.The bottom third of the guide wire stuck in the screw and was not protruding outside the bone so the surgeon left it in the patient.

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.The following sections could not be completed with the limited information provided.Product identification and expiration date - unknown, manufacture date ¿ unknown.Sales rep present at procedure indicated that the wrong size guide wire was used with the screw and that is what caused it to break.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-002842 / 02843).

• Brand Name: UNKNOWN GUIDE WIRE
• Type of Device: FIXATION, FASTENER
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3750701
• MDR Text Key: 20975368
• Report Number: 0001825034-2014-02843
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2014

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability