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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 130 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 130 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 41301180S
Device Problems Positioning Failure (1158); Difficult or Delayed Separation (4044)
Patient Problem Blood Loss (2597)
Event Date 03/05/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Sales rep reported that : "a 130° gamma3 trochanteric nail was placed on a patient as part of a preventive nailing of the right femoral neck, a secondary lesion. The cervical screw got stuck in the nail, making it impossible to screw it in. The nail was removed (with difficulty due to the absence of extraction material in the ancillary instruments used) and the cervical screw couldn't pass through the nail while it passed through the other nail in place. " nail replaced. Surgery delay: yes, time extended by significant amount of time (not aware how long) significant patient bleeding.
 
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Brand NameTROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 130
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 Key9908201
MDR Text Key193101725
Report Number0009610622-2020-00137
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number41301180S
Device Lot NumberKU115031
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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