MAUDE Adverse Event Report: SYNTHES USA 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER; DRILL, BONE, POWERED

Catalog Number 03.505.041

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Additional device product code: dzj.(b)(4).Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 follow: it was reported that on (b)(6) 2016, patient underwent initial procedure.During the procedure, as the doctor finished drilling and tried to take the drill bit out, the drill bit broke.Fragments were generated but could not be located.Broken fragments remained in the patient.An x-ray taken confirmed that the broken fragment is inside the drilled hole in the mandibule.The doctor tried to fix the screw at the hole but it could not be screwed in completely and the plate was not fixed properly.No further action was performed since the site was located very posteriorly deep inside the mouth.There was a 30 minutes surgical delay.Patient outcome was reported as stable.No clinical findings were reported.Revision procedure is not planned.Concomitant medical products: screw (part# unknown, lot# unknown, quantity 1); plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6158047
• MDR Text Key: 61885297
• Report Number: 2520274-2016-15644
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.505.041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ONE (1) UNKNOWN SCREW; ONE (1) UNKNOWN SCREW
• Patient Outcome(s): Required Intervention