MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXNEURO SCREW SELF-DRILLING 4MM; COVER, BURR HOLE

Model Number	04.503.104.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a craniotomy procedure on (b)(6) 2023, the surgeon stated that the screw head broke from the rest of the screw while being inserted, and the screw was only partially inserted into the bone when the screw head broke off.The surgeon also mentioned that this has happened multiple times in the past with the same screws.The patient was not adversely affected, and there was no surgical delay.The screw threads were removed from the bone, and a new plate was placed.The procedure was completed successfully, and the patient outcome was stable.This report involves one ti matrixneuro screw self-drilling 4mm.This is report 1 of 1 for (b)(4).This report is related to (b)(4), which reports the allegation that the issue has happened previously.
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D2b: additional device product codes: gwo, jey.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: TI MATRIXNEURO SCREW SELF-DRILLING 4MM
• Common Device Name: COVER, BURR HOLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17369853
• Report Number: 8030965-2023-08862
• Device Sequence Number: 3784567
• Product Code: GXR
• UDI-Device Identifier: 20887587018345
• UDI-Public: (01)20887587018345
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: 04.503.104.20
• Device Catalogue Number: 04.503.104.20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: TRAUMA
• Patient Sex: Unknown