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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.026
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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) 2018, a patient underwent a trochanteric fixation nail advanced (tfna) procedure. During the surgery, the surgeon tried to take off the percutaneous radiolucent insertion handle after having placed and locked down the tfna femoral nail, titanium alloy and lag screw. However, the connecting screw for insertion handle would not release from the nail. The patient¿s leg was abducted and the connecting screw could not be removed. The surgeon then removed the instrumentation and implants. A new second nail of the same part and different sized lag screw were inserted, and another new second connecting screw and insertion handle were used. The same issue occurred. The connecting screw became stuck to the nail while taking off the second insertion handle. The surgeon was able to disengage the connecting screw from the nail. The second nail and lag screw remained implanted in the patient. It was noted that the nail was not fitting on properly, and that the tips of both insertion handles had become bent or torqued. It was also noted that the screw inserter bent at the handle and the helical blade/screw coupling screw bent at the tip of the threads. There was an unknown surgical delay reported. Additional medical intervention was required. The patient outcome was also unknown. The procedure was successfully completed. Concomitant device reported: trochanteric fixation nail advanced (tfna) screw 100mm - sterile (part 04. 038. 100s, lot h406590, quantity 1); trochanteric fixation nail advanced (tfna) screw 110mm - sterile (part 04. 038. 110s, lot 7859799, quantity 1). This is report 7 of 8 for (b)(4).
 
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Brand NameHELICAL BLADE/SCREW COUPLING SCREW
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7561461
MDR Text Key109839345
Report Number2939274-2018-52384
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 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.026
Device Catalogue Number03.037.026
Device Lot Number9768853
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2016
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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