• 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 NAIL ADAPTER T2 TIBIA SPI 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 NAIL ADAPTER T2 TIBIA SPI ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18061402
Device Problem Sticking (1597)
Patient Problem No Information (3190)
Event Date 10/11/2017
Event Type  malfunction  
Manufacturer Narrative
The evaluation revealed both instruments to be the primary products. No deviations were found during review of the manufacturing and inspection documents (dhr). The instruments were documented as faultless prior to distribution. An investigation was not possible because the instruments were not provided. The root cause could not be determined. Review of complaint history, capa databases and risk analysis did not identify any discrepancies. There are no open actions in place related to the reported event for the subject product(s). No non-conformity was identified. Device not return.
 
Event Description
It was reported that the nail holding bolt got stuck inside nail adapter while trying to load the nail to the adapter. Nail holding bolt initially would seat flush with the adapter while threaded into the nail. Upon trying to unthread from the nail, the surgeon had to use maximum effort to get the bolt to turn in the slightest amount. After eventually getting the nail off of the bolt, the surgeon had to attach nail extraction rod to the nail holding bolt and use a mallet to back slap the bolt out of the adapter. The surgeon tried to put the bolt back in to re attach the nail and was unable to do so. Ultimately had to switch to a smith and nephew system and use their nail. This was the first time these instruments had ever been used.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that the nail holding bolt got stuck inside nail adapter while trying to load the nail to the adapter. Nail holding bolt initially would seat flush with the adapter while threaded into the nail. Upon trying to un thread from the nail, the surgeon had to use maximum effort to get the bolt to turn in the slightest amount. After eventually getting the nail off of the bolt, the surgeon had to attach nail extraction rod to the nail holding bolt and use a mallet to back slap the bolt out of the adapter. The surgeon tried to put the bolt back in to re attach the nail and was un able to do so. Ultimately had to switch to a smith and nephew system and use their nail. This was the first time these instruments had ever been used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAIL ADAPTER T2 TIBIA SPI
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7009409
MDR Text Key254462520
Report Number0009610622-2017-00347
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18061402
Device Lot NumberK0B2888
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 Received03/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/08/2017 Patient Sequence Number: 1
-
-