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

Model Number	IOBP KNEE OPEN TIP PROCEDURE KIT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that an abs-2001-ot iobp core decompression delivery kit had the cutting mechanism break off inside the patient.This occurred during use in a iobp procedure performed on (b)(6) 2021.The fragment was removed from the patient, and the case was completed using a second kit.

• Brand Name: IOBP KNEE OPEN TIP PROCEDURE KIT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12540212
• Report Number: 1220246-2021-03705
• Device Sequence Number: 14296124
• Product Code: FMF
• UDI-Device Identifier: 00888867338531
• UDI-Public: 00888867338531
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: IOBP KNEE OPEN TIP PROCEDURE KIT
• Device Catalogue Number: ABS-2001-OT
• Device Lot Number: 13010384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1