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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

Date of event: date of screw loosening and pain is unknown. This report is for an unknown 3. 5 cortex screw/unknown lot. Part and lot number are unknown; udi number is unknown. Implanted date: unknown. Complainant part is not expected to be returned for manufacturer review/investigation; the device was reportedly discarded. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that a patient underwent removal of one (1) unknown 3. 5 cortex (lag) screw from the distal portion of their tibia because of loosening of the screw and pain. The unknown cortex screw was not a part of any construct and was present as a standalone screw in the patient's tibia. The surgeon was not sure why the screw was implanted into the patient. This cortex screw was present in the tibia just distal to an unknown tibial nail construct, however was not touching it. It is unknown as to when the tibial nail construct and the unknown cortex screw were implanted, and if they were implanted together. The patient presented to the surgeon with pain, and subsequently the surgeon realized that the cortex screw was loose and has elected to remove the screw. The removal procedure was completed successfully by the surgeon, leaving the tibial nail construct behind. There were no complications or surgical delays during this procedure. Two x-rays were taken during the procedure, one initially to locate the loose cortex screw, and second at the end of the procedure to check if everything went well. The patient was reported to be in stable condition at the end of the procedure. This report is for an unknown 3. 5 cortex screw. This is report 1 of 1 for (b)(4).

 
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Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7421297
Report Number2939274-2018-51576
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received03/21/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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