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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.013
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2018
Event Type  malfunction  
Manufacturer Narrative
Patient identifier reported as (b)(6). 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. 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 on (b)(6) 2018, the buttress compression nut would disengage from the 130 degree aiming arm locking device when it was advanced toward the lateral femoral cortex during an orthopedic procedure using a trochanteric femoral nail advance (tfna). The aiming arm would not permit the buttress compression nut to lock in during surgery. It is unknown if there was a surgical delay. There are no reported patient consequences. This report is for a 130 deg aiming arm. This is report 2 of 2 for (b)(4).
 
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Brand Name130 DEG AIMING ARM
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 Key7629030
MDR Text Key112317806
Report Number2939274-2018-52584
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 05/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.013
Device Catalogue Number03.037.013
Device Lot Number9418835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2015
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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