MAUDE Adverse Event Report: Synthes GmbH INSERT FOR FNS INSERTION HANDLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	03.168.009
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction

• Brand Name: INSERT FOR FNS INSERTION HANDLE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Synthes Selzach; bohackerweg 5; selzach CO 80132 ; SZ 80132
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50550606
• Report Number: 8030965-2026-08726
• Device Sequence Number: 18791985
• Product Code: KTT
• UDI-Device Identifier: 07611819657359
• UDI-Public: (01)07611819657359(10)180242-202
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 03.168.009
• Device Lot Number: 180242-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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