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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 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.042S
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
(b)(6). Date of postoperative nail breakage is unknown. The tfna was initially implanted on an unknown date in (b)(6) 2017. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested and is currently pending completion. 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) 2018, the patient underwent a trochanteric fixation nail-advanced (tfna) hardware removal and revision to a total hip arthroplasty due to non-union and a broken proximal portion of the tfna and failed fixation. Patient was x-rayed in the er and the broken nail was identified. The tfna was initially implanted on an unknown date in (b)(6) 2017. Some broken device fragments remained in the patient after the hardware removal. Delayed healing and decreased range of motion (rom) was noted. The procedure was successfully completed and no surgical delay reported. Concomitant devices reported: tfna helical blade l105 tan (part # 04. 038. 305, lot # h334558, quantity 1); 5. 0mm ti locking screw w/t25 stardrive 34mm for im nails (part # 04. 005. 524, lot # unknown, quantity 1). This report is for one (1) 10mm/130 deg ti cann tfna nail. This is report 1 of 1 for complaint (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 170MM - 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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7627292
MDR Text Key111975728
Report Number2939274-2018-52583
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 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.042S
Device Catalogue Number04.037.042S
Device Lot NumberH452737
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 Received07/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/21/2018 Patient Sequence Number: 1
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