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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION,APPARATUS,NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION,APPARATUS,NON-POWERED Back to Search Results
Catalog Number 357.371
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/24/2019
Event Type  malfunction  
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 a trochanteric femoral nail procedure, the locking mechanism that rotationally locks the helical blade or lag screw fell down into the nail during the operation before it was supposed to. The following are the devices used during the insertion of the helical blade: unknown helical blade insertion handle, unknown connecting screw, aiming arm, outer sleeve through the aiming arm. While inserting the helical blade, the blade got stuck halfway between fully inserted and coming out, and unable to extract the helical blade or advance it forward because it¿s a little too in the locking mechanism broke off and got ledge in between the helical blade and the nail itself in the middle. There was a backup device used, the nail and helical blade were removed and a new nail and blade were used. There was a difficulty in the removal. The doctor attempted to use standard tfn extraction instrumentation but was unsuccessful as the helical blade was not able to be removed independently from the nail. Eventually, he extracted both the nail and blade out together. The following are the devices used in the case but are unable to disassemble them: aiming arm, blade guide sleeve and buttress/compression nut. They did not cause any patient harm and were not returned to use. There were no fragments generated from the broken device. There was a surgical delay of thirty minutes. The procedure was completed by taking out the nail with the helical blade still stuck halfway through the eyelet in the nail then another nail was implanted. Patient status is stable. This is report 5 of 5 for (b)(4).
 
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Brand NameBUTTRESS/COMPRESSION NUT FOR 357.369
Type of DeviceTRACTION,APPARATUS,NON-POWERED
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9100697
MDR Text Key195564197
Report Number2939274-2019-60744
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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
Report Date 08/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number357.371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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