MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 14MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.5MMX 14MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgery on (b)(6) 2018 for an open reduction internal fixation of a left trimalleolar ankle fracture with fixation of the distal fibula fracture, posterior malleolus fracture, and syndesmotic fixation.During the (b)(6) 2018 surgery, the following products were used and/or implanted: ar-8740-52pts qckfix scrw,ti,cann st,canc.,4.0x 52mm, lot/serial (b)(6).Ar-8925t k-less t-rope w/drv, syn repr, ti, lot/serial (b)(6).Ar-8933-20 lo-pro scrw,ti,3.0mmx 20mmcort, lot/serial (b)(6).Ar-8933v-12 3.0 x 12mm val screw, ti, lot/serial (b)(6).Ar-8933v-14 3.0 x 14mm val screw, ti, lot/serial (b)(6).Ar-8933v-16 3.0 x 16mm val screw, ti, lot/serial (b)(6).Ar-8933v-18 3.0 x 18mm val screw, ti, lot/serial (b)(6).Ar-8933v-20 3.0 x 20mm val screw, ti, lot/serial (b)(6).Ar-8935-12 lo-pro scrw,ti,3.5mmx 12mm, lot/serial (b)(6).Ar-8935-14 lo-pro scrw,ti,3.5mmx 14mm, lot/serial (b)(6).Ar-8935-14 lo-pro scrw,ti,3.5mmx 14mm, lot/serial (b)(6).Ar-8935-26 lo-pro scrw,ti,3.5mmx 26mm, lot/serial (b)(6).Ar-8943-01 guide wire, trocar tip, 1.35 mm, lot/serial (b)(6).Ar-8943-02 drill bit, cannulated, 2.6mm, lot/serial (b)(6).Ar-8943-16 2.0mm drill bit, calibrated, lot/serial (b)(6).Ar-8943-30 2.5mm drill bit, lot/serial (b)(6).Ar-8943-42 2.5mm drill bit, calibrated, lot/serial (b)(6).Ar-9943bl-04 locking distal fibula plate, ti ,left,4h, lot/serial (b)(6).After surgery, it was reported the patient began to experience allergy like symptoms and on (b)(6) 2018 a revision was performed by the same surgeon and the arthrex devices were removed, including the ar-9943bl-04 (lot (b)(6) and the ar-8925t (lot (b)(6).
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
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 14MM
• 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: 17563205
• Report Number: 1220246-2023-07526
• Device Sequence Number: 15117818
• Product Code: HWC
• UDI-Device Identifier: 00888867050402
• UDI-Public: 00888867050402
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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,TI,3.5MMX 14MM
• Device Catalogue Number: AR-8935-14
• Device Lot Number: 10197846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2018
• 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