MAUDE Adverse Event Report: SYNTHES GMBH FIBULINK REMOV KIT; EXTRACTOR

Catalog Number	FGS-1300
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6), 2025, the patient underwent removal surgery for the fibukink due to bone union.The primary surgery was performed in (b)(6) 2024.The surgeon was following the procedure as usual, but the tibial screwdriver got stuck and when it was removed the height of the tibia and fibula had changed.Therefore, the surgeon tried to remove the fibukink by adjusting the height of the tibia and fibula, but there were several times when the tibial screwdriver got caught on the step and only the tibial screwdriver came out.When reconnecting, it turned a little more vigorous and there was no longer any catch.The threads on either the fibukink or the tibial screwdriver had become stripped, making it difficult to remove, so the surgeon decided to drive the fibukink in and leave it in the body.The surgeon stated that he would like to confirm whether this case was caused by stripped screw threads on the driver.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H.11.Additional narrative: added: h4.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H.11.Additional narrative: added: d9.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the kit is composed by three extraction components.Tibia screw remover and screwdriver were damaged and stripped from the tip.The end tip of the screw remover was also found deformed.With observed condition an issue with correct assembly can be confirmed.The embedded condition on the opposite side cannot be confirmed without the provision of an x-ray.Properly handling and attention to the approved use of the device diminishes the risk of failure.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.Please refer to surgical technique for removal steps fibulink syndesmosis repair system: notes: the tensioning cap remover from the fibulink removal kit is not compatible with implants implanted prior to (b)(6) 2020.If an implant removal is required, use the following instruments: the fibulink removal kit (discard tensioning cap remover).A commercially available t20 screwdriver or conical extraction screw (309.520) from the depuy synthes screw removal set (01.240.001) to remove the tensioning cap.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the fibulink remov kit would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part# fgs-1300.Lot # 24e012.Manufacturing site: robling medical, inc.Supplier: na.Release to warehouse date: 18 jun 2024.Expiration date: 01 jun 2027.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FIBULINK REMOV KIT
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22809209
• Report Number: 8030965-2025-08431
• Device Sequence Number: 12999635
• Product Code: HWB
• UDI-Device Identifier: 00863176000324
• UDI-Public: (01)00863176000324(17)270601(10)24E012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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-1300
• Device Lot Number: 24E012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 09/10/2025; 09/23/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/12/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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 Age: 37 YR
• Patient Sex: Male