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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM / TI CANN FRN / PF 380MM / LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM / TI CANN FRN / PF 380MM / LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.033.139S
Device Problem Difficult to Advance (2920)
Patient Problem No Code Available (3191)
Event Date 05/04/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. (b)(4). 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 had bilateral midshaft femur fractures. On (b)(6) 2020 a surgery was performed with bilateral, antegrade intramedullary nails. The surgeon started on the left femur first, the proximal femur was opened and the canal was reamed to 12. 5mm and proximally to 14mm to accommodate an 11 mm x 380mm left femoral recon nail. The nail was inserted using standard technique and approximately two (2) to three (3) inches from final placement depth, the nail would no longer advance. The surgeon used typical force to advance the nail to its final position, but it would not go any further. A series of ap and lateral x-rays were taken to make sure nothing was impeding the nail path, and nothing was found. The surgeons decided to remove the nail which took an extraordinary amount of force to remove and added time to the procedure. The nail was removed, and the surgeon decided to ream the canal to a larger diameter. The canal was then reamed to 13. 5 mm and the nail was re-inserted. The nail stopped advancing in the same spot, as it had the first time. Even with heavy impaction, it would not advance any further. The surgeons decided to remove the nail which again took an extraordinary amount of force and time to remove. The surgeon decided to switch to a different implant and chose an 11 mm x 380 mm retrograde/ antegrade femoral nail. The new nail went in without incident. The right femur was also treated with an 11 mm x 380 mm retrograde/ antegrade femoral nail. It also went in without incident. There was approximately a thirty (30) minute surgical delay. The procedure was completed successfully. The patient was reported as stable, after the procedure. Concomitant devices reported: reamer (part number unknown, lot unknown, quantity 1). This report involves one (1) 11mm / ti cann frn / pf 380mm / left ¿ sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM / TI CANN FRN / PF 380MM / LEFT - 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)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10065329
MDR Text Key192151584
Report Number2939274-2020-02371
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.033.139S
Device Catalogue Number04.033.139S
Device Lot Number4L45206
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 Received06/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
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: 05/18/2020 Patient Sequence Number: 1
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