MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIX CHIN PL/DOUBLE BEND 5 HOLES/4MM OFFSET/0.7MM THK; PLATE, BONE

Model Number	04.511.461
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Lot number provided was not a valid number.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: initial reporter is a synthes employee.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 colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2022, menton plates and l plates (0.8) were used with screws from another commercial company (fixmedical).The specialist indicated that the diameters of the screws were very small and decided to combine the osteosynthesis materials.The procedure was completed successfully.This report is for a ti matrix chin pl/double bend 5 holes/4mm offset/0.7mm thk.This is report 1 of 2 for (b)(4).

• Brand Name: TI MATRIX CHIN PL/DOUBLE BEND 5 HOLES/4MM OFFSET/0.7MM THK
• 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 ; 3035526892
• MDR Report Key: 14674449
• Report Number: 8030965-2022-03909
• Device Sequence Number: 17492207
• Product Code: JEY
• UDI-Device Identifier: 10887587024431
• UDI-Public: (01)10887587024431
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 04.511.461
• Device Catalogue Number: 04.511.461S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/13/2022
• 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: COMPETITOR SCREWS (FIXMEDICAL); MATRIX 90° L-PLATE SHORT 2+2HO REVERSIBL
• Patient Sex: Female