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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IOBP, CORE DECOMPRESSION AND DELIVERYKIT SYRINGE, PISTON

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ARTHREX, INC. IOBP, CORE DECOMPRESSION AND DELIVERYKIT SYRINGE, PISTON Back to Search Results
Model Number IOBP, CORE DECOMPRESSION AND DELIVERYKIT
Device Problem Break (1069)
Patient Problem Tissue Damage (2104)
Event Date 09/12/2019
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not been returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
The abs-2000-ot was to be used for an intraosseous bioplasty to repair a microfracture of the knee. When the surgeon pushed the syringe into the knee, it snapped off at the attachment. They were unable to complete that part of the procedure. The surgeon had to extend the original incision to use a k-wire to drill and complete the repair.
 
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Brand NameIOBP, CORE DECOMPRESSION AND DELIVERYKIT
Type of DeviceSYRINGE, PISTON
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 Key9141657
MDR Text Key163121549
Report Number1220246-2019-01336
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIOBP, CORE DECOMPRESSION AND DELIVERYKIT
Device Catalogue NumberABS-2000-OT
Device Lot Number10327760
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/25/2019
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: 10/01/2019 Patient Sequence Number: 1
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