MAUDE Adverse Event Report: SYNTHES MONUMENT MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 03.511.248

Device Problem Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).(b)(4).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.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during bimax procedure the surgeon noted the drill bit was overheating and hospital confirmed this was a new drill bit.He also notes that the correct irrigation, speed and all other recommended safety precautions were used during drilling; however he is concerned this could cause an infection or increased risk of breakage as the bone has been damaged.No delay in the surgery was experienced; the surgeon kept using the same drill bit.No adverse event has been reported at this time, but the patient outcome is currently unknown.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was conducted.The report indicates that the: dhr review for part # 03.511.248 supplier lot # u227305.Release to warehouse date: 19-feb-2009.Expiration date: na.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Subject device has been received and an investigation summary was performed; the following complaint device was received by customer quality: one matrix drill bit ø1.4 w/stop l44.5/8 (part number: 03.511.248, lot number: u227305, mfg date: 19feb2009).The part was received with the following complaint description: ¿during bimax procedure the surgeon noted the drill bit was overheating and hospital confirmed this was a new drill bit.The complaint condition is unconfirmed.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The returned instrument is part of the matrixorthognathic plating system, a set of specialized implant and instrument for orthognathic surgery.The drill bit is used in order to predrill prior to the insertion of screws especially in areas with dense bone or to insert screws during selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.As mentioned in the technique guide the drill rate should never exceed 1800 rpm as that may lead to thermal necrosis of the bone, soft tissue burns and an oversized hole to be drilled and to irrigate during drilling.Upon visual inspection of the complaint device no issues were noted.No damaged was seen on the drill bit that may of caused the complaint issue.Additionally no additional information was provided in regards to what drill was used, how fast the drill was being operated at and if irrigation was being done during the procedure.As such the complaint is unconfirmed.Replication of the complaint condition is not applicable as the original circumstances leading to the complaint cannot be replicated at cq.Drawings for the instrument were reviewed.The drawing was found suitable to determine the intended device design, application and dimensional conformity.The instrument was found to have met the drawing specifications.A device history review was performed for all returned instruments lot number and no mrrs, ncrs or complaint-related issues were identified with the lots number which may have contributed to the complaint condition.Synthes manufacturing location was discovered upon receipt of subject device.Device 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/8MM STOP/44.5MM
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6205650
• MDR Text Key: 63310313
• Report Number: 2520274-2016-15775
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.511.248
• Device Lot Number: U227305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2009
• 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 Outcome(s): Required Intervention