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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 41251180S
Device Problems Positioning Failure (1158); Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer (dr. (b)(6)) has reported the following event: "i would like to ask you about a defective 125° short gamma nail. I wanted to insert a short gamma nail this morning for a pertrochanteric fracture. I encountered a problem with the nail locking screw. The cervicocephalic screw was not locking with the proximal locking screw. I mentioned a problem with the cervicocephalic screw. Changing the cervicocephalic screw did not solve the problem. I had to change the 125° short gamma nail, which solved the problem. When testing the nail outside the patient, i found that the locking mechanism of the cervicocephalic screw did not work. I kept the nail in my office in (b)(6). ".
 
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Brand NameTROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM 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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11181082
MDR Text Key227754786
Report Number0009610622-2021-00235
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K043431
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 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number41251180S
Device Lot NumberKU126012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2020
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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