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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 16MM VAL SCREW, TI PLATE, FIXATION, BONE

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ARTHREX, INC. 2.4 X 16MM VAL SCREW, TI PLATE, FIXATION, BONE Back to Search Results
Model Number 2.4 X 16MM VAL SCREW, TI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Swelling (2091); Impaired Healing (2378); Reaction (2414)
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 3/3/20 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.
 
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Brand Name2.4 X 16MM VAL SCREW, TI
Type of DevicePLATE, 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 Key10184151
MDR Text Key198736817
Report Number1220246-2020-01909
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867045606
UDI-Public00888867045606
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
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 Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2.4 X 16MM VAL SCREW, TI
Device Catalogue NumberAR-8724V-16
Device Lot NumberW6677819
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/23/2020 Patient Sequence Number: 1
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