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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1MM THREADED GUIDE WIRE 150MM
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1MM THREADED GUIDE WIRE 150MM Back to Search Results
Catalog Number 292.622
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Information captured on maude report: product problem, original description, complainant part is not expected to be returned for manufacturer review/investigation.Corrections to information captured on maude report: device is an instrument and is not implanted/explanted.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.(b)(4).
 
Event or Problem Description
This report is against maude medwatch number mw5076352.The only information contained in this report is correction or additional information.This is report 1 of 1 for (b)(4).
 
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Brand Name
1.1MM THREADED GUIDE WIRE 150MM
Common Device Name
GUIDE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7496950
Report Number2939274-2018-52090
Device Sequence Number1705087
Product Code FZX
UDI-Device Identifier10886982180728
UDI-Public(01)10886982180728
Combination Product (Y/N)N
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number292.622
Initial Date Received by Manufacturer 04/13/2018
Initial Report FDA Received Date05/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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