MAUDE Adverse Event Report: SYNTHES GMBH; EXTRACTOR

Model Number	309.190
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgical procedure, the trephine broken screw instrument broke when trying to take out a k-wire.Surgeon aware, fluoroscopy used throughout case to ensure no broken pieces left in patient.

• Brand Name: NA
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 20781850
• Report Number: 20781850
• Device Sequence Number: 12012918
• Product Code: HWB
• UDI-Device Identifier: 10886982185662
• UDI-Public: (01)10886982185662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/22/2024
• Report Date (Section F): 11/22/2024

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: 309.190
• Device Catalogue Number: 309190
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Date Report Sent to FDA: 11/22/2024