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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 14MM PLATE, FIXATION, BONE

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ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 14MM PLATE, FIXATION, BONE Back to Search Results
Model Number LOCKING SCREW, TITANIUM 3.5MM X 14MM
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fall (1848); Pain (1994)
Event Date 08/08/2018
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 device disposition was unknown by the reporter. The cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
During social safeguard cyber review (arthrex chatter community) a potential device issue was discovered. Upon further investigation it was confirmed on (b)(6) 2018 that a revision procedure had taken place. Additional information was requested. Additional information obtained 9/5/2018: a patient had a distal radius fracture procedure on (b)(6) 2018. During the procedure the following devices were implanted: ar-8916vnl-03 lot 10183688 (qty 1), ar-8724v-20 (qty 4 lot unknown), ar-8935l12 (qty 1 lot unknown), ar-8935l-14 (qty 1 lot unknown), and ar-8935-12 (qty1 lot unknown). The patient suffered a fall and had a revision procedure on (b)(6) 2018. During the revision procedure all of the original implants were removed and replaced. The following devices were implanted to complete the procedure: ar-8916vnl-03 lot 10189728 (qty1), ar-8724v-18 (qty1 lot unknown), ar-8724v-22 (qty 3 lot unknown), ar-8935l-12 (qty1 lot unknown), ar-8935l-14 (qty 1 lot unknown), and ar-8935-12 (qty1 lot unknown). Per reporter it is unknown when the patients pain began or if patient had any other symptoms prior to the patient's fall. No cultures were taken or any other problems found during revision surgery. The explanted devices are not available to return as the device disposition is unknown by the reporter.
 
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Brand NameLOCKING SCREW, TITANIUM 3.5MM X 14MM
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 Key7890130
MDR Text Key120826732
Report Number1220246-2018-00655
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867050853
UDI-Public00888867050853
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111253
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 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberLOCKING SCREW, TITANIUM 3.5MM X 14MM
Device Catalogue NumberAR-8935L-14
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? No
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: 09/19/2018 Patient Sequence Number: 1
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