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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.063S
Device Problem Break (1069)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Patient id: (b)(6). Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: initial reporter is a synthes sales representative. 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 that on august 26, 2021, the patient underwent a procedure due to a broken trochanteric femoral nailing advanced (tfna) nail. The nail broke at the helical blade/nail interface six months after implantation. The initial fracture was an intertrochanteric with subtrochanteric extension. The broken hardware was removed, and the non-union site was revised with ria bone graft and an angled blade plate. It is unknown if there was a surgical delay. Procedure outcome is unknown. This report is for a tfna nail. This is report 1 of 2 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 420MM/LEFT - 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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12526094
MDR Text Key273117394
Report Number2939274-2021-05744
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.063S
Device Catalogue Number04.037.063S
Device Lot Number69P1867
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 Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2020
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: 09/24/2021 Patient Sequence Number: 1
Treatment
TFNA FENESTRATED HELICAL BLADE 100 -S
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