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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA/TFN/PFNA NAIL, BLADE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA/TFN/PFNA NAIL, BLADE Back to Search Results
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Code Available (3191)
Event Date 07/09/2019
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown nails: tfna helical blade/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; 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 on (b)(6) 2019, the surgeon stated that during an orthopedic procedure he experienced problems with the sliding of the trochanteric femoral nailing advanced system (tfna) blade or screw when using the static locking mechanism with the unknown torque limiting device. Moreover, the surgeon added that he had a series of cases to compare. It was unknown if there were surgical delay and patient consequence reported. Concomitant device reported: unknown torque limiting device (part#unknown, lot#unknown, quantity#1). This complaint involves (2) devices. This (b)(4) captures the intra op event that surgeon experienced problems with the sliding of tfna blade/screw while (b)(4) captures the post of incident where in the surgeon seen a sliding of the helical blade after it has statically locked ( the collapse of the blade has been seen in post-op radiographs. This report is for one (1) unk - nails: tfna helical blade. This report is 2 of 2 for (b)(4).
 
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Type of DeviceTFNA/TFN/PFNA NAIL, BLADE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8867108
MDR Text Key153525355
Report Number2939274-2019-59554
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received08/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/06/2019 Patient Sequence Number: 1
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