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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.290S
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. 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 on (b)(6) 2019, the patient underwent revision surgery due to the fracture collapsed and the trochanteric femoral nail advanced (tfna) helical blade cut out through the femoral head into the joint. The helical blade was removed and no fragments generated. The nail remained and a shorter tfna screw was implanted. Originally, the hardware was implanted on (b)(6) 2018. It is unknown if there was a surgical delay. Procedure was successful. Patient outcome was unknown. Concomitant device reported: unknown distal locking screw (part # unknown, lot # unknown, quantity # unknown), unknown tfna nail (part # unknown, lot # unknown, quantity # 1). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE 90MM 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
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8458316
MDR Text Key140118903
Report Number2939274-2019-57156
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
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.290S
Device Catalogue Number04.038.290S
Device Lot NumberH560165
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 Received04/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/27/2019 Patient Sequence Number: 1
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