MAUDE Adverse Event Report: SYNTHES GMBH; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.120.026
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
2.5mm drill tip guide wire, 300mm.The tip of the guide wire broke off and is in patient's femoral canal.

• Brand Name: NA
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 19228653
• Report Number: 19228653
• Device Sequence Number: 17622140
• Product Code: FZX
• UDI-Device Identifier: 10886982074249
• UDI-Public: (01)10886982074249
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2024
• Report Date (Section F): 01/04/2024

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: 03.120.026
• Device Catalogue Number: 03120026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/04/2024