MAUDE Adverse Event Report: SYNTHES MONUMENT 1.5MM TROCAR DRILL BIT/QC100MM/18MM CALIBRATION; DRILL, BONE, POWERED

Catalog Number 317.876

Device Problem Break (1069)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

It was reported that the matrix 1.4mm drill broke in surgery at the narrow end.No delay was reported and surgery was successfully completed.Patient status is good.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4): 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.

Event Description

It was reported that the 1.5mm trocar drill bit broke in surgery at the narrow end.

Manufacturer Narrative

Additional narrative: the review of the device history records showed that there were no issues or non-conformances during the manufacture of the product that would contribute to this complaint condition.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 1.5mm trocar drill bit, part number 317.876, was received broken approximately 29mm from the distal tip.This is where the diameter begins to increase from 1.5mm.The balance of the tool is in good condition and the etchings are legible.This drill bit is intended for use in mandibular and orthognathic procedures and is to be used at a low speed through a trocar for bicortical drilling.This information is provided per the trocar drill bit product information sheet.The returned drill bit, lot u182211, was manufactured august, 2013 and was received broken into two pieces.The pieces show a clean horizontal break approximately 29mm from the distal tip.This is where the diameter begins to increases from 1.5mm and this distal cone shows wear.The balance of the drill bit is in good condition.Thus, the complaint condition is confirmed but cannot be replicated because the device was received broken.A review of the current edition of the design drawing was performed since the drill bit was manufactured after the release of the current drawing revision.The device was found to show dimensional conformity at the break and the design was found to be sufficient for its intended use.Therefore, this complaint condition is not the result of a design deficiency.The returned condition is consistent with the result from excessive force from use not through a trocar and/or drilling above the recommended speed.Thus, the method of use most likely led to this complaint condition.In conclusion, the complaint condition is confirmed because the drill bit was received broken into two pieces.This is the only complaint for this device family in the complaint history and the design was found to be sufficient for its intended use.Excessive force, most likely from use not through a trocar and/or drilling above the recommended speed, has led to this complaint condition and the risk analysis adequately addresses the complaint condition.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: 1.5MM TROCAR DRILL BIT/QC100MM/18MM CALIBRATION
• 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: 3938524
• MDR Text Key: 18731039
• Report Number: 2520274-2014-12627
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317.876
• Device Lot Number: U182211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 07/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/06/2014; 09/03/2014; 11/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 53