• 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 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° 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 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2016
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported by the nurse of the hospital, that the locking pin 3125-1180s was missing.
 
Manufacturer Narrative
The evaluation revealed the nail kit of the provided package to be the primary product (a different nail kit was originally complained - cat# 3125-1180s). No deviations were found during review of the manufacturing and inspection documents (dhr). The nail kit of the provided package labelling was documented as faultless prior to distribution; the set screw was documented as inserted. The microscopically inspection of the provided plastic blister revealed that a shape of a set screw is visible; furthermore micro-damaged, caused by the set screw thread windings, hitting the plastic during transport movement. Therefore a set screw was inserted within the blister; the complained missing of the set screw could not be confirmed. Most likely the set screw popped out of the package due to rough opening or due to opening upside down (use error). 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.
 
Event Description
It was reported by the nurse of the hospital, that the locking pin 3125-1180s was missing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
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 Key5691555
MDR Text Key46300996
Report Number0009610622-2016-00280
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034002
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 05/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number31251180S
Device Lot NumberK0897DB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/01/2016 Patient Sequence Number: 1
-
-