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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
Catalog Number 03.037.024
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Synthes sales representative. A review of the device history records has been requested. Device was used for treatment, not diagnosis.
 
Event Description
Synthes europe reports an event in (b)(6) as follows: it was reported that during insertion of a trochanteric fixation nail advanced (tfna) nail on an unknown date, the helical blade inserter was not able to pass the threaded coupling screw. The surgeon have to switched from helical blade to lag screw since the coupling screw was able to pass with the insertion handle for the lag screw. It is unknown if there was a surgical delay. Patient status and surgical outcome were both unknown. Concomitant device reported: unknown coupling screw (part# unknown, lot# unknown, quantity unknown). This complaint involves one (1) device. This report is 1 of 1 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
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8062153
MDR Text Key126890946
Report Number2939274-2018-54942
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.024
Device Lot NumberT138805
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/12/2018 Patient Sequence Number: 1
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