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U.S. Department of Health and Human Services

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

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AKROS MEDICAL, INC FIBULINK® SYNDESMOSIS REPAIR KIT/SS; WASHER, BOLT NUT Back to Search Results
Catalog Number FGS-1000
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that, during a procedure the suture of the fibulink syndesmosis repair kit was broken when installing intra-op.Procedure was completed successfully.This report is for one (1) unk - fibulink.This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
This report is for an unk - fibulink/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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.
 
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.H6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image attached in the notes & attachments section of pc titled "(b)(4) device photo (b)(6) 2021".The image was reviewed, and the complaint condition is confirmed.The suture that connects the tensioning cap, fibula link, and tibia screw is broken.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional information.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - no dhr review was completed since no lot number was supplied via photo or additional information.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.
 
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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 (Section G)
ROBLING MEDICAL, INC
90 weathers street
youngsville NC 27705
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12759135
MDR Text Key281537872
Report Number3013401747-2021-00062
Device Sequence Number1
Product Code HTN
UDI-Device Identifier07612334226358
UDI-Public(01)07612334226358
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/12/2021
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
Device Operator Health Professional
Device Catalogue NumberFGS-1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received11/07/2021
Supplement Dates Manufacturer Received12/08/2021
06/16/2022
Supplement Dates FDA Received12/08/2021
06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
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