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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tfna helical blade/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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. (b)(4). 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 the patient underwent total hip arthroplasty on (b)(6) 2018, due to the trochanteric femoral nail advanced (tfna) helical blade protruding medially through the nail and through the femoral head. The patient originally underwent an open reduction internal fixation (orif) of the right femur on (b)(6) 2018. All implants were removed without incident. Procedure was completed successfully with an unspecified delay. Current patient status is unknown. Concomitant devices: screw (part: unknown, lot: unknown, quantity: unknown). This report is for an unknown tfna helical blade. This is report 1 of 2 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key8169421
MDR Text Key130502461
Report Number2939274-2018-55414
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 11/23/2018
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
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 Received01/14/2019
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: 12/17/2018 Patient Sequence Number: 1
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