Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 KIEL TIBIAL NAIL T2 ALPHA? TIBIA Ø9X315MM; 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 KIEL TIBIAL NAIL T2 ALPHA? TIBIA Ø9X315MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2341-0931S
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Perforation (2001); Insufficient Information (4580)
Event Date 03/14/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, revision surgery was performed due to a t2 alpha advanced locking screw backing out of a tibial nail.Implant date was (b)(6) 2022.The nail is still currently implanted in the patient and the advanced locking screw is being held for cultures.Neither implant will be sent back.
 
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains in patient.
 
Manufacturer Narrative
Please note correction to (device code).The reported event could be confirmed, since the migration of the screw is visible on one of the received pictures.The received pictures were reviewed.One picture with the complained screw was provided.Just the upper part of the screw is visible, there are no damages at the visible section of the screw, the reported lot number can be confirmed.One x-ray was received of the proximal end of the nail.Based on this x-ray the migration of the screw cannot be confirmed and no root cause can be defined because just one plane is visible and as no x-ray of the initial situation after the implantation was provided.One picture of the leg below the knee was provided, it is visible that the screw head of a locking screw has pierced the skin.Based on this picture the complained migration of the screw can be confirmed.The nail was not returned for evaluation, therefore no further evaluation is possible and it cannot be defined if the nail did contribute to the migration of the screw.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
On (b)(6) 2022, revision surgery was performed due to a t2 alpha advanced locking screw backing out of a tibial nail.Implant date was (b)(6) 2022.The nail is still currently implanted in the patient and the advanced locking screw is being held for cultures.Neither implant will be sent back.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TIBIAL NAIL T2 ALPHA? TIBIA Ø9X315MM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM   D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14042515
MDR Text Key288786419
Report Number0009610622-2022-00120
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613327290639
UDI-Public07613327290639
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number2341-0931S
Device Catalogue Number23410931S
Device Lot NumberK07759E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age85 YR
Patient SexFemale
-
-