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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 360/RIGHT - SILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 360/RIGHT - SILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.056S
Device Problem Break (1069)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
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. 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 (b)(6) 2021, the surgeon removed a broken tfna from a patient. The original implantation date is unknown. It is unknown if there was a surgical delay. The procedure was successfully completed. Patient outcome was successful. Concomitant devices reported: unknown nail head elements: tfna helical blade (part# unknown, lot# unknown, quantity# 1); unknown screws: locking (part# unknown, lot# unknown, quantity# unknown). 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 Name10/130 DEG TI CANN TFNA 360/RIGHT - SILE
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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11495085
MDR Text Key246494920
Report Number2939274-2021-01320
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.056S
Device Catalogue Number04.037.056S
Device Lot Number39P4527
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 Received04/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2020
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: 03/16/2021 Patient Sequence Number: 1
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