MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0; DRILL, BONE, POWERED

Catalog Number 03.503.476

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required: the drill bit broke intraoperatively.The surgeon extended the incision to locate the fragment of the drill bit for removal.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 patient had original surgery on (b)(6) 2018 for treatment of a mandible fracture.The patient was implanted with one (1) matrix mandible plate and unknown quantity and length of 2.0mm non-locking screws.Intra-operatively, while the surgeon was drilling a pilot hole for screw fixation, the tip of the matrix mandible 1.5mm drill bit broke off inside the patient¿s mandible bone.Due to the broken drill bit, the surgeon needed to extend the incision to expose the exact placement of the drill bit fragment.Also, a c-arm with fluoroscopy device was brought into the operating room to identify the placement of the drill bit tip fragment.Surgeon continued with the procedure and switched to another drill bit.Another event occurred while the surgeon was implanting one (1) of the 2.Mm non-locking screws.The screw head broke off while it was being implanted.The head portion of the screw was removed and disposed of.The surgeon chose to leave the distal portion of this screw shaft inside the patient mandible bone.Surgery was completed successfully with a 90-minute time delay.Hospital has retained the broken items.The patient is reported in stable condition.Concomitant devices: matrix mandible plate (item # unknown, lot number unknown, quantity 1), 2.0mm non-locking matrix mandible screws (item # unknown, lot number unknown, quantity unknown).This report is for one (1) matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Dhr review was completed.Part number: 03.503.476 , synthes lot number: u255057 , supplier lot number: n/a , release to warehouse date: 17-jan-20017 , expiration date: n/a , supplier: (b)(4) , no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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.

• Brand Name: MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7429589
• MDR Text Key: 105439002
• Report Number: 2939274-2018-51661
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587012971
• UDI-Public: (01)10887587012971
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.476
• Device Lot Number: U255057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR