MAUDE Adverse Event Report: Synthes GmbH FIBULINK Syndesmosis Repair Kit Ti; Washer, Bolt Nut

Catalog Number	FGS-1100
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction

• Brand Name: FIBULINK Syndesmosis Repair Kit Ti
• Common Device Name: Washer, Bolt Nut
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50810277
• Report Number: 8030965-2026-09532
• Device Sequence Number: 20993563
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: (01)00863176000317(17)271201(10)24E017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: FGS-1100
• Device Lot Number: 24E017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown