MAUDE Adverse Event Report: SYNTHE USA 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and 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

Medwatch report # 5067933 was received.A copy will be included with the report.It was reported that a patient underwent a surgery to repair multiple facial fractures requiring screws and plates on an unreported date.Upon attempting to place one of the screws, it broke leaving the tip inside the patient's bone.The team attempted to retrieve it, but could not and further attempts to remove it would result in injury to the patient.A decision was made to leave it in.This event did not result in any patient injury nor did it prolong the surgery or patient's hospital length of stay.This complaint involves one (1) device.Concomitant device reported: plate (part # unknown, lot # unknown, quantity unknown).This report is 1 of 1 for (b)(4).

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHE 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: 6443119
• MDR Text Key: 71218693
• Report Number: 2520274-2017-11108
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 02/15/2017,03/07/2017

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/29/2017
• 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