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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.142S
Device Problems Use of Device Problem (1670); Device Difficult to Maintain (3134); Device Handling Problem (3265)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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 an unknown date, during an open reduction internal fixation (orif) of the right femur, the trochanteric femoral nail advanced (tfna) locking mechanism was tightened down before an unknown helical blade was inserted. While putting the implant in, the surgeon noticed a meeting an unusual amount of resistance. The surgeon was able to back the helical blade out, loosening the locking mechanism and complete the procedure without any further difficulty. There was a surgical delay of ten (10) minutes. Procedure was successfully completed. There was no patient consequence. Concomitant device reported: unknown trochanteric femoral nail advanced (tfna) helical blade (part # unknown, lot # unknown, quantity # 1). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TFNA 170MM - STERILE
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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8782194
MDR Text Key150874732
Report Number2939274-2019-59142
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.142S
Device Catalogue Number04.037.142S
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
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

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