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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.031S
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 05/22/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j employee. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 a hip surgery while doing proximal femoral nailing system (tfna) on a midshaft femur fracture, the fracture was reduced, reamed and implanted using a tfna nail. After getting the tfna nail down the canal, the triple sleeve was used to insert the unknown lag screw. The surgeon proceeded with the steps and inserted the unknown lag screw. The surgeon was unsuccessful in locking the set screw. It was found that the nail disconnected from the unknown aiming arm and the unknown lag screw missed the hole in the nail. The surgeon proceeded to extract the nail and was successful in removing it with the extraction hook. The surgeon opened a new nail and properly assembled it onto the aiming arm before implanting the new nail and unknown lag screw and proceeding with the rest of the case. There was a one hundred twenty (120) minute surgical delay. The procedure was successfully completed. The patient outcome is unknown. This complaint involves six (6) devices. This report is for (1) 10mm/125 deg ti cann tfna 400mm/left ¿ sterile. This is report 1 of 6 for (b)(4).
 
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Brand Name10MM/125 DEG TI CANN TFNA 400MM/LEFT - 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 Key10129285
MDR Text Key194467384
Report Number2939274-2020-02655
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.031S
Device Catalogue Number04.037.031S
Device Lot NumberH225115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2016
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: 06/08/2020 Patient Sequence Number: 1
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