MAUDE Adverse Event Report: SYNTHES GMBH FIBULINK® SYNDESMOSIS REPAIR KIT/ TI; WASHER, BOLT NUT

Catalog Number	FGS-1100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that on (b)(6) 2024.The patient, underwent an orif surgery for a bimalleolar fracture of the ankle.In the surgery, the lcp distal fibula plate and the fibulink were used in combination.When using the fibulink, the connection between the fibula link and tensioning cap seemed to be made, when the status was checked by image intensifier.And the surgeon also, felt the connection was made.However, it was found, that the connection was not made, when the silver and gold guide tubes were removed.The sales rep suggested, that the surgeon reinsert the silver and gold guide tubes, reattach the tensioning cap.And then remove the tibia screw.However, the surgeon abandoned those procedures, because of the limited hemodilution time and procedural difficulties.The surgeon remained the tibia screw in the bone and closed the wound.The surgery was completed successfully within 30 minutes delay.The surgeon determined, that there was little instability between the tibia and fibula.And that fixation had no problem.The plate was used in combination of the fibulink, but had no problem.The surgeon commented, that the sensations felt with the demonstration products were different from those felt, during an actual operation, making it difficult.No further information is available.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11: additional narrative: if information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that the patient was stable.No other medical intervention was required and no removal surgery was performed.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post-market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history review: part # fgs-1100; synthes lot # 23e016; supplier lot # 23e016; release to warehouse date: 01 nov 2023.Supplier: (b)(4).No ncr's generated during production.Dhr result retrieved from pi-(b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20691077
• Report Number: 8030965-2024-13952
• Device Sequence Number: 18274963
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: (01)00863176000317(17)261101(10)23E016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: FGS-1100
• Device Lot Number: 23E016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male