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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 Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The initial complaint was reviewed and found not reportable. This was initially assessed as reportable, however the malfunction based on the investigation findings is different than the one reported. This malfunction is non-reportable. 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.
 
Manufacturer Narrative
No patient involvement was reported. Date of event: unknown. Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. Subject device has been received and is currently in the evaluation process. 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 the coupling screw was stuck in the screw insertion handle. This was discovered when putting the trochanteric fixation nail advance (tfna) set back together. The devices are still stuck together. There was no patient 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
MDR Report Key7160585
MDR Text Key281670498
Report Number2939274-2018-50042
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982070425
UDI-Public(01)10886982070425(10)LOTUNKNOWN
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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