MAUDE Adverse Event Report: ARTHREX, INC. EASY-OUT, MICRO COMPRESSION FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	EASY-OUT, MICRO COMPRESSION FT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/04/2023
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 november 3, 2023, it was reported by the surgeon that his patient may be having an allergic reaction to the devices and/or instruments used in a prior surgery.No further information was provided.On (b)(6) 2023, medical records were provided confirming that the surgeon performed a bunionectomy, and 1st metatarsal osteotomy of the left foot was performed on (b)(6) 2020.Arthrex¿s sales records for the patient¿s (b)(6) 2020 procedure indicate the screws implanted during the surgery were arthrex¿s ar-8725-24h compr ft screw,2.5 micro,24mm lgth (lot 10546665), ar-8730-28h compr ft screw,3.5 mini,28mm lgth (lot 10279485) and ar-8730-36h compr ft scrw,3.5 mini, 36mm (lot 10443285).Following the initial surgery, the records indicate that on (b)(6) 2023, a second surgery was performed by the same surgeon to remove a prominent screw in the 1st left metatarsal.During this surgery, multiple arthrex instruments were used to attempt to remove the screw however the procedure was abandoned as the screw was unable to be removed from the bone after multiple attempts with different removal instruments.All screws remain implanted.Those instruments have been identified as arthrex¿s ar-8737-35 drill bit straight cannulated 2.7 m, ar-8737-38 driver, cannulated t10 hexalobe and ar-8737-61 screw extractor mini.The surgeon has requested information related to the devices as the patient is experiencing allergic type reactions.Specifically, an area with a small macular papular rash medial aspect left first ray.No further information was provided.
Additional Manufacturer Narrative
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 of the reported failure can be attributed to patient specific event.Direction for use.Dfu-0110 compression screws.D.Adverse effects.1.Infections, both deep and superficial.2.Foreign body reactions.3.Non-healing due to inadequate blood supply in the area of the repair.The complaint allegation was confirmed based on the documentation provided.

• Brand Name: EASY-OUT, MICRO COMPRESSION FT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18352186
• Report Number: 1220246-2023-09477
• Device Sequence Number: 15575653
• Product Code: LXH
• UDI-Device Identifier: 00888867263802
• UDI-Public: 00888867263802
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: EASY-OUT, MICRO COMPRESSION FT
• Device Catalogue Number: AR-8737-61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 19 YR
• Patient Sex: Male