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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2333-0932S
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2022
Event Type  malfunction  
Event Description
As reported: "during verifying correct alignment by inserting a drill through the sleeve and targeting arm assembly, the drill did not pass through the appropriate hole of the nail (first nail). After that some adjustment was done but the issue did not solve. The physician changed to new different size nail (second nail) and the verification of correct alignment was successful. The procedure was completed without problem using second nail which was different size as the planed size nail. ".
 
Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
 
Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "during verifying correct alignment by inserting a drill through the sleeve and targeting arm assembly, the drill did not pass through the appropriate hole of the nail (first nail). After that some adjustment was done but the issue did not solve. The physician changed to new different size nail (second nail) and the verification of correct alignment was successful. The procedure was completed without problem using second nail which was different size as the planed size nail. ".
 
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Brand NameFEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM
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 Key13418978
MDR Text Key285676148
Report Number0009610622-2022-00038
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2333-0932S
Device Catalogue Number23330932S
Device Lot NumberK036203
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? No
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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