MAUDE Adverse Event Report: SYNTHES GMBH N/A; STAPLE, FIXATION, BONE

Model Number	LARGE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Handpiece did not release staple.

• Brand Name: N/A
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 21034643
• Report Number: 21034643
• Device Sequence Number: 18443387
• Product Code: JDR
• UDI-Device Identifier: 00810633022054
• UDI-Public: (01)00810633022054(17)250721(10)MHC200023
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024
• Report Date (Section F): 12/13/2024

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
• Device Model Number: LARGE
• Device Catalogue Number: 46.239.002
• Device Lot Number: MHC200023
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• 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: Male
• Date Report Sent to FDA: 12/13/2024