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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; SCREW, FIXATION, BONE
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ARTHREX, INC.; SCREW, FIXATION, BONE Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
On (b)(6) 2022 it was reported by a sales representative via email that an ar-8933 cortical screw head broke off.This was discovered during a 1st and 2nd tmt fusion procedure on (b)(6) 2022.The body of the screw remains in the patient and case was completed successfully.
 
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.
 
Manufacturer Narrative
Complaint confirmed, based on the picture provided.Complaint device was not returned for evaluation.The screw broke at the head, since only head of the screw is shown.The cause of this event is undetermined, as the complaint device was not returned for further evaluation.
 
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Brand Name
UNK
Type of Device
SCREW, 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 Key13928186
MDR Text Key296970466
Report Number1220246-2022-04646
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received03/07/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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