MAUDE Adverse Event Report: SYNTHES MONUMENT MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED F/BASIC TROCAR SYS; DRILL,BONE,POWERED

Catalog Number 03.511.343

Device Problem Break (1069)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

It was reported that the drill bit broke during surgery on (b)(6), 2014.There was no time delay in surgery and surgery was completed successfully.Patient outcome was reported as stable.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product codes: erl and hbe.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was completed: (b)(4) manufactured the matrix drill bit.The supplier¿s certificate of compliance indicates the parts were manufactured and met the required specifications.The parts were inspected and conformed to the synthes, incoming final inspection sheet.There were no non-conformance reports generated for this complaint.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product development evaluation was completed: the 03.511.343, lot u160461 basic trocar drill bit, j-latch, calibrated, 125mm was received intact.The distal end of the device is broken off along a homogenous fracture surface and was not returned.The device was manufactured in august 2012 and is two years old.Per the technique guide, the 03.511.343 basic trocar drill bit, j-latch, calibrated, 125mm is an instrument that is also available in the matrixorthognathic plating system.The device was returned and reported to have broken during surgery.This condition is confirmed; the returned device was received with the distal end of the device broken off and not returned.The fracture surface is homogenous and is 2mm from the beginning of the fluting.It is likely that either user error or a collision with something harder than bone led to this condition.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.It is likely that user error or collision with something harder than bone led to this confirmed complaint, however this complaint is not a result of any design related deficiency.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED F/BASIC TROCAR SYS
• Type of Device: DRILL,BONE,POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4002116
• MDR Text Key: 4778592
• Report Number: 1719045-2014-10364
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.511.343
• Device Lot Number: U160461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 57