MAUDE Adverse Event Report: ARTHREX, INC. QUICKSET KIT, 5CC; CALCIUM SULFATE PREFORM PELLET

Model Number	QUICKSET KIT, 5CC
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
On 08/22/2022, it was reported by a sales representative via phone that an abs-3005 quickset kit, 5cc had an issue.During a distal femoral osteotomy (dfo) procedure on (b)(6) 2022, when the surgeon was trying to inject the implant, it never hardened.She gave it an additional 6 minutes past the recommended time, and it still did not harden.The surgeon decided to remove the device with suction, as it started to leak out of the bone.The surgeon then proceeded with the dfo procedure, no new implant was used, and the case was completed successfully with no impact to the patient.

• Brand Name: QUICKSET KIT, 5CC
• Common Device Name: CALCIUM SULFATE PREFORM PELLET
• 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: jared engle ; 8009337001
• MDR Report Key: 19491651
• Report Number: 1220246-2024-05115
• Device Sequence Number: 7090028
• Product Code: MQV
• UDI-Device Identifier: 00888867084384
• UDI-Public: 00888867084384
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231714
• 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): 06/06/2024

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: 09/01/2024
• Device Model Number: QUICKSET KIT, 5CC
• Device Catalogue Number: ABS-3005
• Device Lot Number: 21AAR2262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown