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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 No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
There was no known reported patient involvement associated with the complained event. This an instrument and is not implanted/explanted. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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, the connecting rod would not thread into the lag screw inserter when setting up for a case. Another set was opened and used for the surgery. There was no patient involvement. This report is for one (1) helical blade/screw coupling screw. This is report 2 of 2 for complaint (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 Key7627134
MDR Text Key112037145
Report Number2939274-2018-52582
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 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
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 Number9670717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2015
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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