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 GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • 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 GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 2351-0030
Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2020
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The customer reported that as he was using the t2 alpha basic guide wire handle he noticed that there were screws missing from the handle.The surgeon believes that the device was returned from re-processing with the screws missing.There is no unintended metal in the patient.
 
Manufacturer Narrative
The reported event was confirmed.Visual inspection revealed drill holes, as the counterparts of missing pins, showed traces of intended press-fit.Thus, a dimensional inspection could not be performed.Hardness tests of available units revealed no deficiency.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 labelling did not indicate any abnormalities.Based on investigation an exact root cause could not be determined.A non-conformity report had been opened in order to further investigate and address this issue for further details.
 
Event Description
The customer reported that as he was using the t2 alpha basic guide wire handle he noticed that there were screws missing from the handle.The surgeon believes that the device was returned from re-processing with the screws missing.There is no unintended metal in the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GUIDE WIRE HANDLE IMN INSTRUMENTS
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9684865
MDR Text Key191317702
Report Number0009610622-2020-00045
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07613327361674
UDI-Public07613327361674
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2351-0030
Device Catalogue Number23510030
Device Lot NumberKME912940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2020
Date Manufacturer Received04/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-