MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK COMPRESSION SCREW, SS, 3.5X14MM; BONE FIXATION PLATE

Model Number	KREULOCK COMPRESSION SCREW, SS, 3.5X14MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 01/23/2024, it was reported by a sales representative via phone that a patient underwent a clavicle fracture procedure on (b)(6) 2023 where an ar-2652cl clavicle fracture plate, an ar-8835-14 low profile screw, (2) ar-8835-16 low profile screws, an ar-8835cl-12 kreulock compression screw, (2) ar-8835cl-14 kreulock compression screws, an ar-8835-10 low profile screw, an ar-7268 fibertape® cerclage with tigerlink, and an ar-7268t tigertape® cerclage with fiberlink were implanted.Five weeks post-op, the patient reported hearing or feeling a pop.An x-ray was taken that confirmed that the ar-2652cl plate had broken.On (b)(6) 2024, a revision surgery was performed where the implanted devices were removed.The revision was completed using a device from another manufacturer.
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.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, it was noted that the kreulock compression screw, ss, 3.5x14mm showed no signs of wear or any manufacturing issues.Dimensional testing was performed, and the device met the requirements for drawing c16537-03 in terms of overall length and the outside diameter of the thread length and thread head.No problem found.

• Brand Name: KREULOCK COMPRESSION SCREW, SS, 3.5X14MM
• Common Device Name: BONE FIXATION PLATE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18636096
• Report Number: 1220246-2024-00725
• Device Sequence Number: 18115096
• Product Code: HRS
• UDI-Device Identifier: 00888867323162
• UDI-Public: 00888867323162
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: Health Professional
• Device Model Number: KREULOCK COMPRESSION SCREW, SS, 3.5X14MM
• Device Catalogue Number: AR-8835CL-14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown