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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 105MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 105MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.256S
Device Problems Entrapment of Device (1212); Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn. Product was not returned.   based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis.
 
Event Description
It was reported that on (b)(6) 2018, during a trochanteric fixation nail advanced (tfna) hip surgery, the surgeon presented an x-ray image on (b)(6) 2018, that showed, that the lag screw had collapsed into the nail. This is an intended design of the tfna, however, the surgeon has the option to lack the lag screw in a rigid construct, this was the procedure that was applied. The intention was to hold the reduction in a static position, however, the lag screw collapsed into the nail and it remained in the patient. Patient status is unknown. There was no surgical delay. Procedure was completed successfully. This report is for one (1) 1tfna screw 105mm. This complaint involves two (2) devices. This report is 2 of 2 for (b)(4).
 
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Brand NameTFNA SCREW 105MM - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key8043304
MDR Text Key126293369
Report Number2939274-2018-54865
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.256S
Device Catalogue Number04.038.105S
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 Received12/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/06/2018 Patient Sequence Number: 1
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