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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® Ø10X260MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3425-0260S
Device Problem Break (1069)
Patient Problems Fall (1848); Failure of Implant (1924); Limb Fracture (4518)
Event Date 01/26/2022
Event Type  Injury  
Event Description
As reported: "the fall resulted in a new fracture at the distal end of the nail and subtrochanteric re-fracture and nail deformity. Revision surgery is scheduled on january 28 or 29. ".
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
As reported: "the fall resulted in a new fracture at the distal end of the nail and subtrochanteric re-fracture and nail deformity. Revision surgery is scheduled on january 28 or 29. ".
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM 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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13577965
MDR Text Key285937667
Report Number0009610622-2022-00065
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3425-0260S
Device Catalogue Number34250260S
Device Lot NumberK0E79E6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2018
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: 02/22/2022 Patient Sequence Number: 1
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