MAUDE Adverse Event Report: BIOMET MICROFIXATION LINDEMANN BUR,MED,023,65MM,TIN

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The distributor reported a surgical delay in excess of 30 minutes due to a bur breaking.The date of the surgery was not provided.No foreign body was retained by the patient.

Manufacturer Narrative

The user facility is foreign; therefore a facility medwatch report will not be available.The user facility reported that the complaint item was discarded during the surgery and therefore not available for review by the manufacturer.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: LINDEMANN BUR,MED,023,65MM,TIN
• Type of Device: BUR,MED,023,65MM,TIN
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: amanda sisk ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 3685824
• MDR Text Key: 4297029
• Report Number: 0001032347-2014-00070
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2014

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-0078
• Device Lot Number: 671368
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• 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): Hospitalization; Required Intervention