MAUDE Adverse Event Report: AKROS MEDICAL, INC FIBULINK® SYNDESMOSIS REPAIR KIT/SS; WASHER, BOLT NUT

Model Number FGS-1000

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This report is against user facility medwatch number (b)(4).The only information contained in this report is correction or additional information.This report is for one (1) fibulink® syndesmosis repair kit/ss this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Added expiration date and udi number.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part # fgs-1000.Synthes lot # 21e018.Supplier lot # 21e018.Release to warehouse date: 11 aug2021.Expiration date: 01 jul2024.Supplier: (b)(4).No ncrs were generated during production.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 was used for treatment, not diagnosis.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/SS
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): AKROS MEDICAL, INC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: christopher hammond ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107195721
• MDR Report Key: 12956821
• MDR Text Key: 286013065
• Report Number: 3013401747-2021-00071
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00863176000300
• UDI-Public: (01)00863176000300
• Combination Product (y/n): N
• PMA/PMN Number: K162805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FGS-1000
• Device Catalogue Number: FGS1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention