MAUDE Adverse Event Report: SYNTHES GMBH 1.5 TI MF CORTEX SCREW STPING FLUTES 6; SCREW, FIXATION, BONE

Model Number	400.736E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 3/07/2023, the veterinary surgeon reported that hardware became infected in a dog patient.Patient had multiple craniofacial fractures.Hardware was originally implanted on (b)(6) 2019.She will be removing the hardware later this month ((b)(6) 2023).He have included all of the implants used in the original surgery.They are unsure which ones caused the infection.They will be removing all of the plates & screws.No new hardware will be implanted.This complaint involves fourteen(14) devices.This report is for one (1) 1.5 ti mf cortex screw stping flutes 6.This complaint is related to these complaints: (b)(4).This is report 12 of 14 for complaint (b)(4).
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.Device used in a veterinary case - no patient information will be reported.Additional codes: mqn, dzl.Complainant part is not expected to be returned for manufacturer review/investigation.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.
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.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: 1.5 TI MF CORTEX SCREW STPING FLUTES 6
• Common Device Name: SCREW, FIXATION, 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: 16614919
• Report Number: 8030965-2023-03658
• Device Sequence Number: 17420707
• Product Code: HWC
• UDI-Device Identifier: 10887587044941
• UDI-Public: (01)10887587044941
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K981275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400.736E
• Device Catalogue Number: 400.736E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/12/2023
• 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: 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6; 1.5 TI MF CORTEX SCREW STPING FLUTES 6
• Patient Sex: Unknown