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 UNKNOWN TARGET DEVICE; 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 UNKNOWN TARGET DEVICE; INSTRUMENT Back to Search Results
Catalog Number UNK_KIE
Device Problems Failure to Align (2522); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer reported that the gamma nail broke and was revised.During the revision case, the customer had significant difficulty noisy drilling for the lag screw.The new lag screw was too short and they changed the length.However, upon removing the new shorter lag screw they realized it was badly scored.The surgeons feel that the jig isn¿t accurate.
 
Manufacturer Narrative
Correction: refer to d10/h3 device availability, h6 device code.The reported event, instrument ¿ mis-drilling, was not confirmed.Review of complaint history, labelling and capa databases could not be performed since no catalog and / or lot number was communicated.The risk analysis did not identify any discrepancies more detailed information about the complaint event such as the surgeon¿s pre-operative tests or why he did not stop drilling when he realized ¿noisy drilling¿ must be available in order to determine the root cause of the complaint event.Pre-operative functional testing is required in the labelling.Potential misalignment causing mis-drilling with damage of implants can easily be detected during required functional check prior to use.The root cause for alleged mis-drilling could not be determined.In case the instrument and / or other essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.H3 other text : device disposition is unknown.
 
Event Description
The customer reported that the gamma nail broke and was revised.During the revision case, the customer had significant difficulty noisy drilling for the lag screw.The new lag screw was too short and they changed the length.However, upon removing the new shorter lag screw they realized it was badly scored.The surgeons feel that the jig isn¿t accurate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN TARGET DEVICE
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9813326
MDR Text Key191476639
Report Number0009610622-2020-00101
Device Sequence Number1
Product Code KTT
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 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-