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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR TI; WASHER, BOLT, NUT

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ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR TI; WASHER, BOLT, NUT Back to Search Results
Model Number KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2024
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On 1/15/2024, it was reported by an arthrex subsidiary employee via email that an ar-8926t knotless tightrope syndesmosis repair implant had an issue.During an open reduction and internal fixation of ankle fracture surgery on (b)(6) 2024, the round plate was found to loosen due to a broken suture.The procedure was completed using another new ar-8926t; no secondary procedure is needed.All broken sutures were retrieved from the patient.Additional information received on 1/31/2024: there was a ten-minute delay in the case without adverse effects on the patient.
 
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Brand Name
KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Type of Device
WASHER, BOLT, NUT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
jared engle
8009337001
MDR Report Key18659384
MDR Text Key334791555
Report Number1220246-2024-00821
Device Sequence Number1
Product Code HTN
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K043248
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberKNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Device Catalogue NumberAR-8926T
Device Lot Number28562
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/15/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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