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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø15X400 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø15X400 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18251540S
Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report. The package in question is available.
 
Event Description
The sterile packed t2 femur nail was unwrapped, the undamaged cardboard box was opened and the nail given to the sterile nurse. Afterwards it was recognized that the inner blister had a crac that ran for about 25 cm along the side of the blister and also across to the other side. The nail was considered to be unsterile. The nail was removed from the sterile field, the drapes that were touched were exchanged and the nail cleaned and sterilized. The nail was then implanted as no other nail of this dimension was available in (b)(6). The nail was removed from the sterile field and put into a washing machine for cleaning, afterwards packed separately and then put into the sterilisation. Material that was touched by the potentially contaminated nail was exchanged for new. Surgical delay of 210 min. Not longer. No other consequences reported. As the surgery was only finished on (b)(6) 2018 potential problems resulting from the long surgery time could not be detected at this time.
 
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Brand NameFEMORAL NAIL, A/R T2 FEMUR Ø15X400 MM
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 Key7345572
MDR Text Key102877094
Report Number0009610622-2018-00075
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K010801
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 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18251540S
Device Lot NumberK034D43
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 Received06/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2017
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: 03/16/2018 Patient Sequence Number: 1
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