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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP PLATE, FIXATION, BONE

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ARTHREX, INC. LOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP PLATE, FIXATION, BONE Back to Search Results
Model Number LOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/01/2020
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 that a patient had undergone a procedure (b)(6) 2020. The first week of (b)(6) 2020 the patient had a follow up visit at the surgeon's office and x-rays taken during the follow up showed a foreign body is present. The item had not been seen on the intraoperative x-rays taken at the time of procedure. It was also reported that the foreign body is not causing any pain or discomfort to the patient. Surgeon believes that the foreign body may be a thin shaving from the narrow ulnar plate/plate screws that had been implanted. Surgeon also indicated that he has seen this occur previously with the arthrex system that was used. (information has been requested regarding these instances. ) the shaving was not noticed at the time of occurrence to determine the specific product the shaving may have come from. At this time the surgeon does not have plans to remove the hardware or foreign body but the sales representative has requested that the surgeon notify him if a second surgery is scheduled. The following are the plate and screws that were used during the (b)(6) 2020 procedure: ar-8916vnl-03, volar distal radius plate, lot 10440051. Ar-8724-18, low profile screw, lot w652321. Ar-8724v-16, val screw, lot w689081. Ar-8724v-18, val screw, lot 1204022. Ar-8724v-18, val screw, lot w698661. Ar-8735-10, low profile screw cortical, lot 2698961. Ar-8735-11, low profile screw cortical, lot 2689741. Ar-8735-13, low profile screw cortical, lot 2689771. Ar-8735-14, low profile screw cortical, lot 2716281. Ar-8735l-12, low profile locking screw, lot 2706701. Ar-8735l-14, low profile locking screw, lot 2706691.
 
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Brand NameLOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP
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 Key10460668
MDR Text Key204894962
Report Number1220246-2020-02100
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867288317
UDI-Public00888867288317
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150456
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberLOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP
Device Catalogue NumberAR-8735-14
Device Lot Number2716281
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/27/2019
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: 08/27/2020 Patient Sequence Number: 1
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