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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 380MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.159S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device is expected to be returned for manufacturer review/investigation, but has not been received yet. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, 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, patient underwent a removal of (tfna) proximal femoral nailing system due to painful non-union. During procedure, upon extracting the tfna helical blade, the extraction instrument for tfna helical blade and screw would not work. The surgeon had to use the helical blade/screw coupling screw to remove the blade. There was also a distal locking screw that broke and both pieces were removed. Additionally, surgeon had issues engaging the extraction instrument for nails, cannulated to the top of the nail and said it¿s not tapped and very tough to engaged in to the nail. The extraction instrument for nails finally engaged, and the nail was removed. The surgeon then proceeded to insert a smith and nephew nail and the surgery was completed with no issues. It is unknown if there was any surgical delay. Patient status is unknown. This (b)(4) captures the post-operative broken screw. (b)(4) captures the intra-operative event occurred during removal. This report is for one (1) tfna nail. This is report 2 of 3 for (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TFNA 380MM/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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8157120
MDR Text Key130174030
Report Number2939274-2018-55377
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.037.159S
Device Catalogue Number04.037.159S
Device Lot NumberH513989
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 Received03/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2017
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: 12/12/2018 Patient Sequence Number: 1
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