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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN 11X400 GAMMA NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN 11X400 GAMMA NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Fracture (1260); Difficult to Remove (1528)
Patient Problems Failure of Implant (1924); Necrosis (1971); Injury (2348); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 06/21/2020
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
This report is for the second surgery to remove the remainder of the nail on (b)(6) 2020. Nail removal, left femur. Reason for nail removal is avascular necrosis, there were no allegations against the implants prior to removal. However, during removal only the proximal part of the nail came out. Surgeon reported the nail must have already been broken proximal to the lag screw while in situ. The remainder of the nail was left in the patient and removed in a second procedure the next day as the needed universal extraction kit was not available in the hospital. The rep confirmed no further information is available.
 
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Brand NameUNKNOWN 11X400 GAMMA NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10286398
MDR Text Key199750336
Report Number0009610622-2020-00325
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
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: 07/16/2020 Patient Sequence Number: 1
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