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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREW, TI GAMMA3® Ø8X17.5MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL SET SCREW, TI GAMMA3® Ø8X17.5MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3003-0822S
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
As reported: "surgeon is performing a gamma operation. When he is to place the set screw he is not able to get the set screw to connect with the lag screw. The set screw is locked in the nail before it connects with the lag screw. They try with another set screw and gets the same result. They then remove the nail and try outside the patient. Again the same result. Both set screws are tightened in the nail before reaching the lag screw. They then took a new nail with another lot no. And were then able to perform the operation. The patient was unnecessarily under anesthesia for an hour where the surgeon and nurses tried to find a solution. ".
 
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
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Brand NameSET SCREW, TI GAMMA3® Ø8X17.5MM
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 Key13577398
MDR Text Key285955863
Report Number0009610622-2022-00064
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K032244
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 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3003-0822S
Device Catalogue Number30030822S
Device Lot NumberK094536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2020
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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