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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2353-3103
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition is unknown.
 
Event Description
It was reported: "patient had an in situ femoral gt alpha nail, placed at (b)(6) hospital about two weeks ago for a second stage revision due to infection. Exchange nail today intended for definitive fixation. Patient on lateral position. After the removal of the in situ nail, ream as normal. Checked nail alignment before introducing. Hydroset placed on femoral head and neck. Nail covered on antibiotics paste. Nail introduced on femoral canal. Inferior wire placed, satisfactory ap and lateral x-ray views. Drilling of superior sleeve on ap view, recon lag screw placement satisfactory on ap view, however, lateral x-ray view confirmed screw was posterior to the nail. Re attempt to drill no satisfactory, going posterior to the nail again. Drilled the inferior hole satisfactory on both ap and lateral x-ray views. Recon lag screw placement satisfactory in both views. Re attempt to drill again superior hole, now with the inferior hole having the screw through, again missed, posterior to the nail. Decided to proceed to distal locking and only one recon lag screw was placed".
 
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Brand NameTARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
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 Key12050187
MDR Text Key260111197
Report Number0009610622-2021-00578
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2353-3103
Device Catalogue Number23533103
Device Lot NumberKP431239
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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