MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 14MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 14MMCORT
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
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) 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
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Upon visual inspection, it was noted that the low profile screw¿, ss, 3.5 x 14 mm, cortical showed normal signs of wear around the hexalobe edges and radius of the head.No manufacturing issues were found.Dimensional testing was performed, and the device met the requirements for drawing c18816-03 in terms of overall length and the outside diameter of the thread length.The most likely cause of this failure is normal wear and tear from repeated screwing and unscrewing of the device.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 14MMCORT
• Common Device Name: BONE FIXATION SCREW/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: 18637534
• Report Number: 1220246-2024-00741
• Device Sequence Number: 18073844
• Product Code: HWC
• UDI-Device Identifier: 00888867047280
• UDI-Public: 00888867047280
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• 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: LO-PRO SCRW TM,SS 3.5X 14MMCORT
• Device Catalogue Number: AR-8835-14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 02/04/2024
• 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