MAUDE Adverse Event Report: SYNTHES MONUMENT TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 04.503.206.01C

Device Problem Break (1069)

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

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).510k reported as: k083388.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

Device report from synthes on an event in (b)(6) as follows: it was reported that during the surgery, the surgeon had implanted the screw and the screw head broke off after implantation.Removal of the same was not done, patient not harmed.The surgery was not extended by any amount of time.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional device product code: jey.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

Further it was reported that the patient underwent an orbital fracture fixation on (b)(6), 2017.Surgeon removed the broken fragment.Surgery was completed successfully.No other medical intervention was required.Patient outcome was normal.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• 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: 6846335
• MDR Text Key: 86576774
• Report Number: 1719045-2017-10884
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.206.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• 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