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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D12XL360 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D12XL360 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2339-1236S
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2022
Event Type  malfunction  
Manufacturer Narrative
The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device is not available; device remains implanted in patient.
 
Event Description
It was reported; "the doctor used a t2 alpha retrograde nail on a periprosthetic fracture. When implanting the nail, the fracture was well reduced. When the nail was fully inserted it kicked the fracture into extension. He was frustrated that he didn't use a competitor's nail with the 10 deg bend. There's no immediate consequences. The fracture just has a smaller chance of healing appropriately since it is now in about 8 deg of extension. ".
 
Manufacturer Narrative
The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device is not available; device remains implanted in patient.
 
Event Description
It was reported; "the doctor used a t2 alpha retrograde nail on a periprosthetic fracture. When implanting the nail, the fracture was well reduced. When the nail was fully inserted it kicked the fracture into extension. He was frustrated that he didn't use a competitor's nail with the 10 deg bend. There's no immediate consequences. The fracture just has a smaller chance of healing appropriately since it is now in about 8 deg of extension. ".
 
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Brand NameT2 FE RETRO NAIL LNG D12XL360
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 Key13509386
MDR Text Key285539383
Report Number0009610622-2022-00046
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203819
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 05/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2339-1236S
Device Catalogue Number23391236S
Device Lot NumberK0A48FC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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