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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 440MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.065S
Device Problem Break (1069)
Patient Problems Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. (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 on (b)(6) 2020 the patient underwent a revision procedure due to a broken trochanteric fixation nail advanced (tfna). The issue occurred when the patient fell and experienced left hip pain. An x-ray was taken which revealed a new femur fracture and a broken tfna. During the revision procedure, the broken tfna was removed then the patient was revised to a new tfna implant. The revision procedure was successfully completed without any surgical delay. The patient status good. Concomitant devices: tfna screw (part # 04. 038. 210s, lot # unknown, quantity 1), unknown tfna end cap (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown). This report is for one (1) 10mm/130 deg ti cann tfna 440mm/left - sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 440MM/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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10786156
MDR Text Key214586258
Report Number2939274-2020-04968
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.065S
Device Catalogue Number04.037.065S
Device Lot Number9925395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2015
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: 11/04/2020 Patient Sequence Number: 1
Treatment
TFNA FENESTRATED SCREW 110MM - STERILE; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING
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