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

MAUDE Adverse Event Report: STRYKER TRAUMA GMBH / STRYKER GMBH STRYKER SUPRAPATELLAR T2 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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
 

STRYKER TRAUMA GMBH / STRYKER GMBH STRYKER SUPRAPATELLAR T2 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problems Break (1069); Positioning Problem (3009)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 07/18/2019
Event Type  No Answer Provided  
Event Description
Please be advised that while investigating an event involving one of our products, depuy synthes noted a nonunion regarding a non-synthes product. We have satisfied the reporting requirements for the depuy synthes product(s) and are providing notice regarding the mfr noted below: (b)(4). It was reported on an unk date, the pt underwent total knee arthroplasty surgery with a suprapatellar t2 nail (stryker's product). On an unk date, the pt fractured femur again (for unk reason). On (b)(6) 2019, she underwent open reduction internal fixation surgery with lcp distal femur plates and the tap for cortex screws in question. The surgeon tried to insert a cortex screw in a proximal hole. When the surgeon inserted the second cortex screw, he could not insert it because of the torque limitation mechanism of the driver. When the surgeon used the tap instead of the driver to insert the screw, the bit of the tap broke when the cortex screw reached contralateral cortical bone. The fragment of the tap remained in the body. The surgery was delayed by less than 30 mins. The alert date is (b)(6) 2019 ((b)(6)). No further info is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRYKER SUPRAPATELLAR T2 NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA GMBH / STRYKER GMBH
MDR Report Key9118779
MDR Text Key160532703
Report NumberMW5090031
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/12/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received09/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-