MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 16MM; SCREW, FIXATION, BONE

Model Number LO-PRO SCRW,TI,3.5MMX 16MM

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Rash (2033); Impaired Healing (2378); Reaction (2414); No Code Available (3191)

Event Date 03/13/2020

Event Type  Injury  

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 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 6/1/20: 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: LO-PRO SCRW,TI,3.5MMX 16MM
• Type of Device: SCREW, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 10184123
• MDR Text Key: 199991126
• Report Number: 1220246-2020-01905
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867050426
• UDI-Public: 00888867050426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.5MMX 16MM
• Device Catalogue Number: AR-8935-16
• Device Lot Number: 10412931
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other