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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 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.056S
Device Problems Failure to Align (2522); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2018
Event Type  malfunction  
Manufacturer Narrative
Patient date of birth and weight were not provided for reporting. Device was implanted on (b)(6) 2018 and remained implanted. Device explant date is not applicable. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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, patient underwent surgery. During the surgery, while using the hip tfna nail, the surgeon went to take the locking mechanism of the nail down and it wouldn¿t budge. They were unable to see on the x-rays whether the nail was up or down, so they had to take the blade and nail out and put them back in again. This time, the locking mechanism moved without a problem. Due to this, twenty-five (25) minutes were added to the procedure. The procedure was completed successfully with no harm to the patient. Concomitant devices reported: helical blade (part# unknown, lot# unknown, quantity 1). This report is for one (1) 10mm/130 deg ti cann tfna 360mm/right ¿ sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 360MM/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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7440255
MDR Text Key106078980
Report Number2939274-2018-51806
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982096128
UDI-Public(01)10886982096128
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
Report Date 04/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.056S
Device Catalogue Number04.037.056S
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 Received04/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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