• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.142S
Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2018
Event Type  malfunction  
Manufacturer Narrative
Patient¿s height reported as 6 feet. Due to the intra-operative events, the device was not successfully implanted. An alternate device was used to complete procedural step. As such, implant/explant dates are not applicable. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. 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 the patient underwent orthopedic procedure on (b)(6) 2018. During the procedure, the surgeon mistakenly advanced the pre-assembled locking screw (locking mechanism inside nail) in the proximal end of the tfn-advanced proximal femoral nailing system (tfna) after nail insertion, but before helical blade insertion. By doing so, the locking screw inhibited advancement of the helical blade when insertion of blade began, thereby damaging/bending the locking screw prong and helical blade. The implants were extracted and inspected, noticing that the cause of the event was the locking screw prong was obstructing passage of the blade. A new tfna nail and new blade was then inserted without incident. There was unknown surgical delay and patient outcome. Concomitant device reported: tfna helical blade 110mm (part# 04. 038. 310, lot # 9848146, quantity 1), unknown distal locking screws (part # unknown, lot # unknown, quantity unknown). This report is for one (1) 11mm/130 deg ti cann tfna 170mm - sterile. This is report 1 of 1 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name11MM/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 Key7795526
MDR Text Key117580447
Report Number2939274-2018-53374
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 07/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.142S
Device Catalogue Number04.037.142S
Device Lot NumberH591010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-