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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative
Patient information is unknown this report is for an unknown tfna nail/unknown lot. Part and lot number are unknown; udi number is unknown. Device has not been reported as explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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. 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 there was difficulty removing the insertion handle from the trochanteric fixation nail advanced (tfna) nail during a trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2018. The surgeon had to chisel away the top of the connecting screw to get the screw out, which extended the surgery by ten (10) minutes. The patient was reported to be doing fine at the end of the surgery. This report is for an unknown tfna nail. This is report 2 of 3 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7659108
MDR Text Key113042727
Report Number2939274-2018-52703
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
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/03/2018 Patient Sequence Number: 1
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