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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 105MM - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 105MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.038.105S
Device Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Patient height reported as 5 feet 7 inches. Patient id/initials are unknown. Unknown date in 2018. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 the patient underwent a revision procedure on may 15, 2018 due to a fall and trochanteric fixation nail advanced (tfna) lag screw cut-out of the femoral head. The nail was removed and the patient was revised to a dynamic hip and condylar screw system (dcs). Surgical delay and patient outcome are unknown. The patient was initially implanted with the hardware on (b)(6) 2018. After the initial surgery, the patient fell on an unknown date causing the lag screw cut-out. Concomitant devices reported: 9mm/125 degree titanium cannulated tfna 235mm/left - sterile (part 04. 037. 915s, lot h484110, quantity 1), screw (part unknown, lot unknown, quantity 1). This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. 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
Further it was reported that the nail and screw were removed easily. No surgical delay was reported and the procedure was completed successfully. Concomitant medical products: 9mm/125 degree titanium cannulated tfna 235mm/left - sterile (part # 04. 037. 915s, lot # h484110, quantity # 1), 5. 0mm titanium locking screw w/t25 stardrive 46mm for intramedullary nails (part # 04. 005. 536, lot # unknown, quantity # 1).
 
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Brand NameTFNA SCREW 105MM - 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)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7570232
MDR Text Key110109273
Report Number2939274-2018-52411
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
Type of Report Initial,Followup,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.038.105S
Device Catalogue Number04.038.105S
Device Lot NumberH395899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/05/2018 Patient Sequence Number: 1
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