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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.130S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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) 2020, during an open reduction internal fixation (orif) of the right femur while inserting the unknown helical blade for the trochanteric femoatal nail advanced (tfna) system, the unknown blade missed the tfna nail. The surgeon took the nail out and started over with a new unknown nail. The surgeon used the same unknown helical blade and this time it went fine. The procedure was completed successfully with a surgical delay of twenty-five (25) minutes. The patient outcome was unknown. Concomitant devices reported: unknown helical blade (part# unknown, lot# unknown, quantity). Unknown helical blade inserter (part# unknown, lot# unknown, quantity). Unknown spiral combination hammer (part# unknown, lot# unknown, quantity). This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/125 DEG TI CANN TFNA 400MM/RIGHT - 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 Key10426792
MDR Text Key208935739
Report Number2939274-2020-03655
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.130S
Device Catalogue Number04.037.130S
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 Received07/25/2020
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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