MAUDE Adverse Event Report: SYNTHES GMBH 2.4 TI MATRIXMANDIBLE SCREW STPING 16; PLATE, BONE

Model Number	04.503.446.01
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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.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 on (b)(6) 2023, the surgeon on his orthognathic cases uses three screws in a triangle intraorally to fixate the mandible advancement on both sides.He has been doing this technique with the same drill / tap and appropriate screws for the past 15 years.Now he advised the screws are not holding they are pulling out.Procedure was completed successfully with a slight delay.This report is for one (1) 2.4mm ti matrixmandible screw self-tapping 5mm.This is report 8 of 10 for complaint (b)(4).

• Brand Name: 2.4 TI MATRIXMANDIBLE SCREW STPING 16
• 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: 17344509
• Report Number: 8030965-2023-08905
• Device Sequence Number: 12486169
• Product Code: JEY
• UDI-Device Identifier: 10887587020976
• UDI-Public: (01)10887587020976
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063790
• 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: 04.503.446.01
• Device Catalogue Number: 04.503.446.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/18/2023
• 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: 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; 2.4 TI MATRIXMANDIBLE SCREW STPING 5; TAP FOR 2.4MM CORTEX SCREWS 125MM/45MM TAPPING
• Patient Sex: Unknown