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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 95MM ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 95MM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.395
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number the device history records review could not be completed. 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. 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) 2020, the patient underwent removal of trochanteric femoral nail advanced (tfna) system and was revised to a shorter unknown lag screw due to lateral protrusion of the helical blade. The tfna system was originally implanted on an unknown date. Patient had clinical findings of decreased range of motion. There was no surgical delay reported. The procedure was successfully completed. Patient outcome was okay. Concomitant devices reported: unknown tfna nail (part # unknown, lot # unknown, quantity # 1), unknown locking screw (part # unknown, lot # unknown, quantity # unknown). This is report 1 of 1 for (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 95MM
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10453329
MDR Text Key204370620
Report Number2939274-2020-03798
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.395
Device Catalogue Number04.038.395
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 Received07/29/2020
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: 08/26/2020 Patient Sequence Number: 1
Treatment
UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
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