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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 07/29/2018
Event Type  Injury  
Manufacturer Narrative
Patient identifier, date of birth, gender, and weight not available for reporting this report is for an unknown aiming arm/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but 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 patient underwent a trochanteric fixation nail advanced (tfna) procedure for a left femur shaft fracture on (b)(6) 2018. During the procedure, the fracture was anatomically reduced. Surgeon reamed 1. 5mm over the diameter of the nail. While attempting to rotate the nail within the canal, surgeon applied heavy torque to the aiming arm attached to the nail. When the lag screw was drilled for and implanted, the lateral x-ray confirmed the lag screw was outside the nail. The screw was removed and surgeon reattempted to tighten the coupling screw back to the top of the nail to then re-insert the lag screw, but the lag screw still missed the nail. Surgeon opted to leave the lag screw out and used two (2) distal locking screws. Surgery was completed successfully with a delay of approximately 10 minutes. This report is for one (1) unknown aiming arm. This is report 3 of 3 for (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key7779481
MDR Text Key117000649
Report Number2939274-2018-53312
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 07/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received07/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/13/2018 Patient Sequence Number: 1
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