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

Model Number FGS-1000

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

It was reported that on (b)(6) 2021, the patient underwent an unknown surgical procedure.A couple of x-rays of the fibulink implant show that it loos like the tensioning cap had broken off causing the implant to fail.The revision surgery was performed on (b)(6) 2021.The fibulink was removed and another fibulink was inserted in its place.The surgeon removed the fibula that was determined on x-ray to be implanted incorrectly or to have failed after implantation.The surgery took approximately one hour.We used the fibulink removal kit as well as the synthes trauma screw removal.The implant was removed using a reverse thread easy out with minimal complication.The removal process took approximately 10 minutes and came out and in two pieces as expected.Upon inspecting the removed implant it was determined that the head of the fibulink button had broken off during orifinak implantation.A new fibulink was then inserted and tightened to satisfaction and deltoid ligament repair was done using arthrex soft tissue implants.The surgeon noted that it was a successful removal and re-implantation.There was no surgical delay.The patient has not returned yet for a follow-up check-up.The procedure was completed successfully.This report is for one (1) fibulink(r) syndesmosis repair kit/ss.This is report 1 of 1 for (b)(4).

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.H10 additional narrative: h3, h6: visual inspection: the complaint device fibulink® syndesmosis repair kit/ss was returned to customer quality (cq) west chester for investigation.The fibulink tensioning cap and tibial screw with broken threads were received.The tensioning cap head had broken off and was not returned.Both screw and the cap were deformed which would have happened during removal of the implants.Document /specification review: the manufacturing date was not available for the device.Hence, the latest revision was reviewed.Fibulink syndesmosis repair kit, ss fgs-1000 dimensional inspection: a dimensional inspection was not performed as a complaint relevant dimension could not be measured due to the design of the implant.Conclusion: the complaint on the fibulink was confirmed during investigation.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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(R) 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, PA ; SZ ; 6107195721
• MDR Report Key: 12771355
• MDR Text Key: 280467086
• Report Number: 3013401747-2021-00063
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00863176000300
• UDI-Public: 00863176000300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-1000
• Device Catalogue Number: FGS-1000
• Device Lot Number: 21E016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male