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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 100MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 100MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.200S
Device Problem Break (1069)
Patient Problem Necrosis (1971)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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) 2021, the patient underwent for a femoral nail removal of titanium cannulated proximal femoral nailing system (tfna) due to tfna nail and fenestrated lag screw were broken. The nails were removed, and a total hip was implanted. The procedure and patient outcome are unknown. Concomitant device reported. Unknown distal locking screw (part# unknown, lot# unknown, qty unknown). Unknown end caps (part# unknown, lot# unknown, qty unknown). This complaint involves (2) devices. This report is for (1) tfna fenestrated screw 100mm, sterile. This report is 2 of 2 for (b)(4).
 
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Brand NameTFNA FENESTRATED SCREW 100MM - 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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12071136
MDR Text Key262178738
Report Number2939274-2021-03249
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
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.200S
Device Lot NumberH537419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2018
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: 06/25/2021 Patient Sequence Number: 1
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