MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 18MM VAL SCREW, TI; PLATE, FIXATION, BONE

Model Number	2.4 X 18MM VAL SCREW, TI
Health Effect - Clinical Codes	Rash (2033); Impaired Healing (2378); Reaction (2414); No Code Available (3191)
Date of Event	03/13/2020
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.
Event or Problem Description
It was reported through the product team that a sales rep has reported a possible patient reaction incident involving an arthrex volar plate.The material composition information was provided to the sales rep, for the surgeon, by the product team.Additional information provided 6/1/2020: the patient had undergone a distal radius fracture orif procedure on (b)(6) 2020.The patient had the initial post op visit on (b)(6) 2020 at which time the patient was taken to the or for and irrigation and debridement for a presumed infection.Cultures has all been negative: negative aerobic, anaerobic, fungal and afb.Symptoms of drainage, blistering, rashes and wound healing issues have all been assessed by the surgeon, infectious disease and dermatology.Patient has been treated to date with steroids and antibiotics (topical and oral).It is unknown if patient has been tested for specific known allergies however it has been reported that patient has developed allergic reaction to almost everything (adhesive, suture, prep, multiple antibiotics).The patient has an allergist visit scheduled for (b)(6) 2020.The following are the arthrex devices that were implanted during the (b)(6) 2020 procedure: ar-8916vnr-03, volar drp nrw rt 3 hole, lot 10299223.Ar-8935-16, lo-pro screw, 3.5x16mm, lot 10412931.Ar-8935-14, lo-pro screw, 3.5x14mm, lot 10229247.Ar-8935-14, lo-pro screw, 3.5x14mm, lot 10294237.Ar-8916cx24-22, low profile screw, 2.4mm x 22mm cortex, lot 171745.Ar-8724v-16, 2.4 x 16mm val screw, ti, lot w6677819 (qty 4).Ar-8724v-18, 2.4 x 18mm val screw, ti, lot w698661 (qty 2).Ar-8935l-14, locking screw, titanium 3.5mm x 14mm, lot 10251644.Ar-8935l-16, locking screw, titanium 3.5mm x 16mm, lot 10395918.

• Brand Name: 2.4 X 18MM VAL SCREW, TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10184188
• Report Number: 1220246-2020-01910
• Device Sequence Number: 2729599
• Product Code: HRS
• UDI-Device Identifier: 00888867045613
• UDI-Public: 00888867045613
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 2.4 X 18MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-18
• Device Lot Number: W698661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other