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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI; PLATE, FIXATION, BONE

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ARTHREX, INC. LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI; PLATE, FIXATION, BONE Back to Search Results
Model Number LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI
Device Problems Break (1069); Entrapment of Device (1212); Difficult to Insert (1316)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/31/2022
Event Type  malfunction  
Event Description
On 10/31/2022, it was reported by a sales representative via phone that a ar-18714-08, ar-18714-07, and a ar-18714-09 screw broke.This occurred during a phalanx fracture on (b)(6)2022 when inserting the ar-18714-08 screw it broke about 3/4 of the way, the surgeon then attempted to insert a ar-18714-09 screw to secure the plate to the bone, upon insertion the screw broke.Then a ar-18714-07 screw was used to secure the plate as it was already down, when attempting to secure the plate it broke.All broken fragments remain in the patient.The patient had very good bone quality and the sockets were prepped for insertion with a ar-18700-06 drill bit.
 
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.
 
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Brand Name
LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI
Type of Device
PLATE, FIXATION, BONE
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
vik bajnath
8009337001
MDR Report Key15833671
MDR Text Key307779159
Report Number1220246-2022-05769
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI
Device Catalogue NumberAR-18714-07
Was Device Available for Evaluation? No
Date Manufacturer Received10/31/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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