MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE EMERGENCY SCREW 6MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number	04.503.236.01
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).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.H11 additional narrative: d2b.Additional pro-code: 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.
Event or Problem Description
It was reported that the complaint regarding the 6mm self drilling matrix midface screws.While doing a midface case with one of the surgeons and four of the 6mm screws broke while being inserted into the patient's zf suture.The surgeon tried to remove them to reposition the plate but all four heads broke off.He attempted to remove them but was unable to.He ended up burring them down, repositioned the plate and moved on.Another set (matrix combo) was pulled and utilized the screws in this set which worked flawlessly.Surgery completed successfully, patient status/ outcome in good standing.This report is for one (1) ti matrixmidface emergency screw 6mm.This is report 3 of 4 for complaint (b)(4).

• Brand Name: TI MATRIXMIDFACE EMERGENCY SCREW 6MM
• Common Device Name: SCREW, FIXATION, INTRAOSSEOUS
• 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: 19374956
• Report Number: 8030965-2024-06604
• Device Sequence Number: 7678280
• Product Code: DZL
• UDI-Device Identifier: 10887587019321
• UDI-Public: (01)10887587019321
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K050608
• 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 Catalogue Number: 04.503.236.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI MATRIXMIDFACE EMERGENCY SCREW 6MM; TI MATRIXMIDFACE EMERGENCY SCREW 6MM; TI MATRIXMIDFACE EMERGENCY SCREW 6MM
• Patient Age: 18 YR
• Patient Sex: Female