MAUDE Adverse Event Report: SYNTHES USA 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 201.932

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Event is a reportable device malfunction only; adverse event and required intervention should not have been checked.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for (qty 1) for self-drilling screw of unknown lot.(b)(4).Part of device remains in the patient; device not considered explanted during the revision/initial procedure on (b)(6) 2017.Device is unavailable for return.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.

Event Description

It was reported that two intermaxillary fixation (imf) screws broke during a procedure on (b)(6) 2017.A patient underwent an initial open reduction internal fixation to treat bilateral fractures of the mandible.Two imf screws broke off half way up the length of their shafts as the surgeon implanted them into the mandible.The surgeon determined to leave the portions of the embedded screws in place and easily retrieved the broken off pieces.There was a surgical delay of a few of minutes.The procedure was successfully completed and patient outcome stable.Concomitant medical products: screwdriver with holding sleeve (part# unknown, lot# unknown, quantity: 1).This is report 2 of 2 for (b)(4).

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 12MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6391018
• MDR Text Key: 69475156
• Report Number: 2520274-2017-10792
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SCREWDRIVER, (PART/LOT UNKNOWN) QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR