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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 Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
Reportedly there was no patient involvement. Date of event is unknown. Implant and explant date is not applicable. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). A device history record review was requested. 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 that following a successful tfna procedure it was discovered that a helical blade inserter and connecting screw would not screw back together. This discovery was made as the sales consultant and hospital staff were resetting the tray. The sales consultant reported noticing that the threads seemed to be stripped. He is unsure when or how this occurred. There was no patient or procedure involvement. This is report 1 of 1 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 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7425446
MDR Text Key105680087
Report Number2939274-2018-51614
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 03/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
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 Number9560695
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2015
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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