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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.462S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arthritis (1723)
Event Type  Injury  
Manufacturer Narrative
Udi number unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. 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 an unknown date, it was notified by the surgeon that the tfna patient was missed the helical blade nail. The nail revised several days later. The patient now has arthritis of the hip and possible infection of the old surgical area. The surgeon recommended for additional surgery to clear up the infection, removal of the tfna hardware and possible total hip arthroplasty. The patient was in adverse conditions. This complaint involves unknown number of devices. This report is for (1) 14mm/130 deg ti cann tfna 420mm/ right-sterile. This is report 1 of 3 (b)(4). Related product complaint: (b)(4).
 
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Brand Name14MM/130 DEG TI CANN TFNA 420MM/RIGHT-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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11334885
MDR Text Key232352250
Report Number2939274-2021-00889
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,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.037.462S
Device Lot Number18P6543
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 Received03/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/16/2021 Patient Sequence Number: 1
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