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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/130 DEG TI CANN TFNA 170 - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/130 DEG TI CANN TFNA 170 - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.142S
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Date of event: unknown when nail broke. Implant date unknown date in (b)(6) 2022 and explant date unknown date in (b)(6) 2022 concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation. No code is for revision surgery. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. 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 a patient presented with hip pain. Radiographs were taken on an unknown date where it was observed that a trochanteric fixation nail advanced (tfna) nail had broken. The nail had broken approximately, to the point where the helical blade passes through the nail. Revision surgery was completed on a unknown date in (b)(6) 2022 where all hardware was removed and the patient was revised to a hemiarthroplasty of the left hip. No fragments were retained, all pieces were removed. The tfna was originally implanted on an unknown date in (b)(6) 2022. This is report 1 of 1 for (b)(4). This report is for a tfna nail.
 
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Brand Name11/130 DEG TI CANN TFNA 170 - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14597214
MDR Text Key293338013
Report Number2939274-2022-02068
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982096548
UDI-Public(01)10886982096548
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.142S
Device Catalogue Number04.037.142S
Device Lot Number524P163
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/03/2022 Patient Sequence Number: 1
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