MAUDE Adverse Event Report: ARTHREX, INC. QUICKSET KIT, 8CC; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	QUICKSET KIT, 8CC
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
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.
Event or Problem Description
It was reported that during a procedure the black plunger top of the abs-3008,quickset kit (lot 19har1191), popped out of the dual-chambered syringe tube when expelling the air/ migrating the calcium phosphate mixture up to the tip of the dual-chambered syringe.The black plunger top popped out and hit the surgeon's face shield, ricocheting and contaminating the device itself and the back table as well.They were able to finish the procedure with a new abs-3005 quickset kit from the facility inventory.There are no pictures of the complaint device and the complaint device is not able to be returned for evaluation.The staff immediately draped and discarded the product.The procedure was a hardware removal of another manufacturer's proximal humerus plate.

• Brand Name: QUICKSET KIT, 8CC
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11258731
• Report Number: 1220246-2021-02515
• Device Sequence Number: 4228676
• Product Code: MQV
• UDI-Device Identifier: 00888867084407
• UDI-Public: 00888867084407
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K093343
• 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): 02/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: QUICKSET KIT, 8CC
• Device Catalogue Number: ABS-3008
• Device Lot Number: 19HAR1191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/01/2021
• 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