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

Model Number	IOBP, CORE DECOMPRESSION AND DELIVERYKIT
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: IOBP, CORE DECOMPRESSION AND DELIVERYKIT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9141657
• Report Number: 1220246-2019-01336
• Device Sequence Number: 2145508
• Product Code: FMF
• UDI-Device Identifier: 00888867284876
• UDI-Public: 00888867284876
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 05/31/2024
• Device Model Number: IOBP, CORE DECOMPRESSION AND DELIVERYKIT
• Device Catalogue Number: ABS-2000-OT
• Device Lot Number: 10327760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other