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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® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3425-1360S
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Implant Pain (4561)
Event Date 05/04/2022
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
As reported: "gamma nail is broken. The patient required revision surgery. " additionally the patient had sudden exertional pain on the morning of (b)(6) 2022. The patient was revised to a cementless stem and bipolar cup.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM 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 Key14574968
MDR Text Key293185177
Report Number0009610622-2022-00213
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613252273837
UDI-Public07613252273837
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K200869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3425-1360S
Device Catalogue Number34251360S
Device Lot NumberK023705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received09/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2021
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: 06/02/2022 Patient Sequence Number: 1
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