MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DIRECTGUIDE¿ DRILL EXTENDER

Model Number DGDE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Tool was found to be out of process tolerance with the possibility of an adverse event.This action is to prevent an adverse event.

Event Description

Dgde tool found with no retention on mate.

Manufacturer Narrative

All the data on this form are correction and additional information to the initial report.

• Brand Name: DIRECTGUIDE¿ DRILL EXTENDER
• Type of Device: DRILL EXTENDER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: terrance abid ; 3050 e. hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 5187863
• MDR Text Key: 30047525
• Report Number: 3001617766-2015-00002
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DGDE
• Device Catalogue Number: DGDE
• Device Lot Number: 67055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1