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, BALL-TIPPED, STERILE T2 FEMUR 3X1000 MM; 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, BALL-TIPPED, STERILE T2 FEMUR 3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 1806-0085S
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 07/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event or Problem Description
It was reported the tip of the k wire broke in two pieces; one piece was retrieved, but the second piece was unable to be removed, and remained stuck in the patient's bone.The remaining piece was less than 1cm in length.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR 3X1000 MM
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key12237842
Report Number0009610622-2021-00624
Device Sequence Number3761387
Product Code LXH
UDI-Device Identifier04546540195937
UDI-Public04546540195937
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician Assistant
Type of Report Initial
Report Date (Section B) 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1806-0085S
Device Catalogue Number18060085S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date07/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age84 YR
-
-