MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; PLATE, BONE

Catalog Number	04.503.206.01C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Swelling/ Edema (4577)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
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.H10 additional narrative: b3: only the event year is known.D9: complainant part is not expected to be returned for manufacturer review/investigation.D2b: additional device product codes: dzl.E3: reporter is a j&j employee.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
Device report from synthes reports an event in australia as follows: it was reported that on (b)(6) 2023, two mandible plates were removed from the patient.The screws, and therefore the plates, had become loose.Some of the screws had backed out from the mandible.The whole construct was removed, including two plates and eight screws.The patient experienced some mild discomfort and localized swelling.When the plates and screws were removed, bicortical screws were inserted to fixate the mandible.The implants had been placed on (b)(6) 2023.The removal surgery was completed successfully.It is felt by the surgeons they are likely getting an element of thermal necrosis in the bone due to the power tool (none synthes product) they are using.This is causing the loss of bone and therefore the screws are backing out.This report involves one ti matrixmidface screw self-tapping 6mm.This is report 7 of 9 for (b)(4).
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.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 MATRIXMIDFACE SCREW SELF-TAPPING 6MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17729048
• Report Number: 8030965-2023-11416
• Device Sequence Number: 14921463
• Product Code: JEY
• UDI-Device Identifier: 10887587018812
• UDI-Public: (01)10887587018812
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.503.206.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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: TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM.; TRUMATCH MDFC/MND TI 3D PRNT PL/MND/MINI.; TRUMATCH MDFC/MND TI 3D PRNT PL/MND/MINI.; UNK - PLATES: MANDIBLE LOCKING.; UNK - PLATES: MANDIBLE LOCKING.; UNK - SCREWS: CMF.; UNK - SCREWS: CMF.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male