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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 41251180S
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
At the time the surgeon was going to implant the gamma nail, the arch became trapped in the nail entry thread. At the time the surgeon tried to remove the arch, it had to be removed with the implant included. Additionally, it was necessary to remove all screws that were place into the patient. To finished the surgery it was necessary to open a new implant and the patient had to receive double anesthesia for the operative time.
 
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Brand NameTROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM 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
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9319339
MDR Text Key191823652
Report Number0009610622-2019-00920
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K043431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number41251180S
Device Lot NumberKU110654
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2019
Was Device Evaluated by Manufacturer? Yes
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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