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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.012
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is unknown. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter email address is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history records review has been requested. 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 during an unknown procedure on (b)(6) 2018, the surgical technician and surgical assistant had difficulty putting the tfn-advanced proximal femoral nailing system (tfna) nail onto the complete radiolucent insertion handle. The tfna nail did not easily connect onto the insertion handle. No known surgical outcome and surgical delay. Patient outcome is unknown. Concomitant devices: 11mm/130 deg ti cann tfna 170mm ¿ sterile (part: 04. 037. 142s, lot: unknown, quantity: 1). This report is for a complete radiolucent insertion handle. This is report 1 of 1 for (b)(4).
 
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Brand NameCOMPLETE RADIOLUCENT INSERTION HANDLE
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 HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7548434
MDR Text Key109368159
Report Number2939274-2018-52324
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,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.012
Device Catalogue Number03.037.012
Device Lot Number9426238
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2015
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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