MAUDE Adverse Event Report: SYNTHES GMBH 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM; PLATE, BONE

Catalog Number	04.511.225.01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent orthognathic surgery involving the upper and lower jaw on (b)(6) 2023.It has been determined by the surgeon and orthodontist that the maxillary surgery is stable, however, the mandibular portion is not and must be revised.Imaging performed on an unknown date showed unstable fixation and malocclusion, so a revision surgery is planned for the near future.This report involves one 1.85mm ti matrix screw self-drilling/5mm this report is related to (b)(4) which capture additional impacted products.This is report 3 of 10 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.H10 additional narrative: b3: only the event year is known.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: concomitant products are as follows: ti matrix oblique l-pl/3x3 h medium/reversible/0.7mm thk (x3), 1.85mm ti matrix screw self-drilling/5mm (x20), 1.85mm ti matrix screw self-tapping/5mm (x8), ti matrix curved sagittal split plate/6 holes/6mm bar (x2), ti matrix oblique l-pl/3x3 h medium/reversible/0.7mm thk (x4), 1.85mm ti matrix screw self-tapping/6mm (x4), matrix 1.4mm drill bit j-latch/6mm stop/44.5mm (x1).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: 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM
• Common Device Name: PLATE, BONE
• 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: 17451289
• Report Number: 8030965-2023-09738
• Device Sequence Number: 7347838
• Product Code: JEY
• UDI-Device Identifier: 10887587023618
• UDI-Public: (01)10887587023618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.511.225.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female