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

Model Number 400.736E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/07/2023

Event Type  malfunction  

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.Additional product codes: hwc,mqn.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.

Event Description

It was reported that on 3/07/2023 veterinary surgeon reported that hardware became infected in a dog patient.Patient had multiple craniofacial fractures.Hardware was originally implanted on (b)(6) 2013.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 report is for one (1) 1.5 ti mf cortex screw stping flutes 6 this is report 5 of 5 for complaint (b)(4).

• Brand Name: 1.5 TI MF CORTEX SCREW STPING FLUTES 6
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• 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: 16622458
• MDR Text Key: 312072031
• Report Number: 8030965-2023-03705
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587044941
• UDI-Public: (01)10887587044941
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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?: Yes
• Device Operator: 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
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention