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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 110MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 110MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.110S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Event date is unknown date in 2018. 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. A review of the device history records 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, the patient underwent a revision surgery of a lag screw and a titanium cannulated trochanteric femoral nailing advanced (tfna) short nail. It was a 110 mm screw that collapsed laterally. Patient reported issues of pain and irritation at the side of the hip and tissue area. The screw was removed, and the shorter 90 mm screw was put in place. After the surgery, the surgeon viewed the x-ray from the original surgery and reported he statically locked the lag screw on the original surgery to prevent guided collapse due to the reverse oblique fracture pattern. The tfna and screw was originally implanted on (b)(6) 2018. There was no delay in the revision surgery. Procedure was successfully completed. Patient outcome was successful. Concomitant device reported: titanium cannulated tfna (part# 04. 037. 142s, lot# h171125, quantity 1). This report is for one (1) tfna screw 110mm - sterile. This is report 1 of 1 for (b)(4).
 
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Brand NameTFNA SCREW 110MM - 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)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8171065
MDR Text Key130609768
Report Number2939274-2018-55424
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.110S
Device Catalogue Number04.038.110S
Device Lot Number7920235
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 Received01/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2015
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: 12/17/2018 Patient Sequence Number: 1
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