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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1822-0936S
Device Problem Difficult or Delayed Separation (4044)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Customer reported that : "procedure: double tibia-fibula fracture. Placement of a tibial nail with a handpiece. At the end of the operation, during the removal of the handpiece, the tibial nail remained stuck on the nail holder of the ancillary. After multiple attempts, it was impossible to detach the nail from the ancillary. The surgeon was forced to explant the nail and screws put in place and perform a new bore. Change of nail with obligation to drive a bigger nail because no other nails of the same size in stock. " delay : 1h opening of a new ancillary instrument set and placement of a bigger nail.
 
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Brand NameTIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM
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 Key9703382
MDR Text Key191322928
Report Number0009610622-2020-00047
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K003018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1822-0936S
Device Catalogue Number18220936S
Device Lot NumberK03F292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2019
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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