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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IOBP HIP OPEN TIP PROCEDURE KIT SYRINGE, PISTON

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ARTHREX, INC. IOBP HIP OPEN TIP PROCEDURE KIT SYRINGE, PISTON Back to Search Results
Model Number IOBP HIP OPEN TIP PROCEDURE KIT
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/21/2022
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 (b)(6) 2022, it was reported by a sales representative via email that abs-2010-ot internal mechanism broke while the surgeon was trying to flip the flipcutter for a decompression. This was discovered during a procedure. No additional information provided. Additional information requested. Additional information received 1/24/2022: this was discovered during an iobp procedure. Device broke when surgeon tried to flip the flipcutter to decompress, there was a pop, and the flipcutter would not flip nor would it drill. This occurred during use; however no pieces came loose inside the patient. Surgeon was able to use a reamer to decompress the bone and complete case.
 
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Brand NameIOBP HIP OPEN TIP PROCEDURE KIT
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 Key13471766
MDR Text Key287804354
Report Number1220246-2022-04419
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00888867338548
UDI-Public00888867338548
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 Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIOBP HIP OPEN TIP PROCEDURE KIT
Device Catalogue NumberABS-2010-OT
Device Lot Number13348143
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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