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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.
 
Event Description
The customer reported that the patient on traction table. Surgery to implant a t2 alpha nail was proceeding as normal, checked nail alignment before introducing nail into femoral canal, all normal. Nail down, ap x-ray view satisfactory, wire introduced in sleeve a (inferior), good position on ap. Lateral view, wire anterior, modified the nail position, second attempt wire goes through femoral neck and head. Satisfactory. Go back to ap view and position of the nail now is to high, retrieve wire, retrieve sleeves, nail introduced further down in canal. After this point we were not able to pass the wire through the sleeve. Wire tip broke on lateral cortex. Pre drilling lateral cortex was advised but ignored. Change the procedure to gamma nail. We did check the jig attachment to the nail and it was tight, no loosen observed. Removal of t2 alpha nail in the case and implantation of gamma nail.
 
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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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12018276
MDR Text Key256777764
Report Number0009610622-2021-00564
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 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
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 NumberKP431228
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 Manufactured04/01/2019
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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