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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1896-5050S
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)
Event Date 05/09/2022
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The customer reported a broken gamma3 nail (3525-0360s). "the patient was treated externally for a per/subtrochanteric left femur fracture on (b)(6) 2021 with a with a gamma nail. During the consultation (b)(6) 2022, the implant fracture was diagnosed and the patient was admitted to hip clinic at balgrist university hospital for further treatment. Here the indication for revision was given in case of symptomatic pseudarthrosis. The indication for revision was given and the patient had to undergo surgery on (b)(6) 2022. " 7/22/2022 - additional information: upon product return, one locking screw was found broken.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
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 Key15260489
MDR Text Key298240432
Report Number0009610622-2022-00385
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540202512
UDI-Public04546540202512
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1896-5050S
Device Catalogue Number18965050S
Device Lot NumberK0542A0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received09/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2020
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: 08/19/2022 Patient Sequence Number: 1
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