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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.024
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 05/25/2018
Event Type  malfunction  
Manufacturer Narrative
Device is an instrument and is not implanted/explanted. Reporter email address is unknown. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. (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 during assembly of trochanteric femoral nail-advance (tfna) instruments on (b)(6) 2018, the helical blade screw coupling screw got cross threaded in the inside back of the helical blade inserter. Prior to loading the selected helical blade, the coupling screw became stuck, not allowing for engagement with the helical blade or removal of coupling screw from the helical blade inserter. The surgeon had already attached the aiming arm and insertion handle to the nail and then manually loaded the helical blade into the helical blade screw drive sleeve and tapped it in with a hammer using the helical blade inserter by itself, without the coupling screw. Using this alternative technique, the helical blade was placed without any additional issues. The surgery was successfully completed with a 15-minute delay due to the intraoperative events. The patient was reported to be stable at the end of the procedure. This report is for a helical blade inserter. This is report 2 of 2 for (b)(4).
 
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Brand NameHELICAL BLADE INSERTER
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)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
SZ 78532
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7630242
MDR Text Key112316764
Report Number2939274-2018-52588
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 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.024
Device Catalogue Number03.037.024
Device Lot NumberT118570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2015
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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