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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X400MM X 120° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X400MM X 120° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 32200400S
Device Problem Break (1069)
Patient Problems Edema (1820); Pain (1994)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The pharmacist at the hospital reported the following event : "early fracture of the device implanted on (b)(6) 2017, observed on a patient who had an edematous and painful thigh to active mobilization. Revision with ablation of the long broken gamma nail and implantation with another long gamma nail on (b)(6) 2017.
 
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Brand NameLONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X400MM X 120°
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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7310474
MDR Text Key101411275
Report Number0009610622-2018-00061
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number32200400S
Device Lot NumberK0D11C4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/21/2016
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: 03/02/2018 Patient Sequence Number: 1
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