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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,30MM LGTH PLATE, FIXATION, BONE

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ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,30MM LGTH PLATE, FIXATION, BONE Back to Search Results
Model Number COMPR FT SCRW,2.5 MICRO,30MM LGTH
Device Problems Break (1069); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 07/18/2019
Event Type  Injury  
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.
 
Event Description
It was reported during a revision screw removal procedure, as the surgeon was coring out the bone around the implanted 2. 5 headless compression screw, the head of the screw broke off and became stuck inside of the ar-8737-59 screw extractor/trephine. The screw broke off flush below the cortex, and the body of the screw was left implanted in the bone. The rep stated the primary procedure took place approximately 2-3 years ago. The reason for the revision was due to the screw protruding 2-3mm out of the bone. The protruding screw was causing pain and discomfort for the patient. The primary procedure was performed by a different surgeon. The rep confirmed the ar-8737-59 and broken screw head will be returning for evaluation. The rep stated they currently do not have any additional details regarding the primary procedure. Additional information received on 07/30/2019: the rep stated the primary procedure was a mtp fusion procedure, and the part and lot numbers of arthrex devices implanted during the primary procedure are unknown. The rep reported the part and lot number of the 2. 5 headless compression screw that the surgeon was attempting to explant during the revision procedure is unknown. It is unknown when the implanted screw was discovered protruding. The rep reported there were not any other arthrex devices explanted during the revision procedure. There are not any de-identified copies of x-rays available. Additional information received on 09/05/2019: the rep reported the part number of the screw that the surgeon was attempting to remove during the revision procedure was ar-8725-30h, 2. 5 x 30mm headless screw (lot unknown). The original procedure was an orif rt first met and took place on (b)(6) 2015. The pre-op diagnosis was rt first met fx.
 
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Brand NameCOMPR FT SCRW,2.5 MICRO,30MM LGTH
Type of DevicePLATE, 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 Key9119561
MDR Text Key163123427
Report Number1220246-2019-01331
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150456
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCOMPR FT SCRW,2.5 MICRO,30MM LGTH
Device Catalogue NumberAR-8725-30H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/25/2019 Patient Sequence Number: 1
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