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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34251380S
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Non-union Bone Fracture (2369); Implant Pain (4561)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported, during treatment a long gamma3 nail was fractured. The patient had a gamma3 nail in place a few months ago and recently it appeared during the inspection that it had broken. Doctors performed the re-surgery on may 19.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10155610
MDR Text Key195249735
Report Number0009610622-2020-00292
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number34251380S
Device Lot NumberK070732
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2018
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: 06/15/2020 Patient Sequence Number: 1
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