MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB; 1.5MM ADJUSTABLE SELF-DRILLING TAP

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/16/2014

Event Type  Injury  

Event Description

The customer reports the tip of the bone tap broke during surgery.The tip was removed from the patient, however, a forty minute surgical delay was reported.

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore, a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.Upon the completion of the device evaluation a follow-up report will be sent.

Manufacturer Narrative

Upon evaluation the tap was found to be broken in the threaded portion, confirming the complaint.The thread minor and major diameters were found to be within tolerance.There were no indications of manufacturing defects.The most likely underlying cause of the complaint issue is excessive force applied to the tap.Fields were updated based on the device evaluation.

• Brand Name: LACTOSORB
• Type of Device: 1.5MM ADJUSTABLE SELF-DRILLING TAP
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle coldwater ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4356799
• MDR Text Key: 5175956
• Report Number: 0001032347-2014-00404
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• 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,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• 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: 915-1595
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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