MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM; SCREW FIXATION INTRAOSSEOUS

Model Number 04.503.226.01

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code: jey.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant.Facility telephone is not available for reporting.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.(b)(4).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 during a facial fracture procedure on an unknown date, the screw heads of two (2) titanium matrixmidface screws broke during final tightening.The broken fragments were removed easily.However, the screw shaft, as well as a portion of the screw heads remain embedded in the patient.A surgical delay of five minutes occured as a result of the removal of the part of the broken screw head.There was no patient harm.Concomitant devices reported: screwdriver (part number unknown, lot number unknown, quantity 1).This report is for one (1) titanium matrixmidface screw self-drilling 6mm.This is report 1 of 2 for (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.Event: clarified event circumstances.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

The screws broke while being tightened by hand with an unknown screwdriver.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7691257
• MDR Text Key: 114087124
• Report Number: 2939274-2018-52901
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587019178
• UDI-Public: (01)10887587019178
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.226.01
• Device Catalogue Number: 04.503.226.01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/06/2018
• Patient Sequence Number: 1
• Treatment: SEE DESCRIPTION; SEE DESCRIPTION, THERAPY DATE
• Patient Outcome(s): Required Intervention
• Patient Weight: 83