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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA TIBIA 12X255MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA TIBIA 12X255MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2341-1225S
Device Problem Positioning Failure (1158)
Patient Problem Limb Fracture (4518)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device discarded.
 
Event Description
As reported: oblique fracture of the distal 1/3 of the tibia. Perform flexible reaming up to f13 and insert f12 × 255 mm nails. At the time of nail insertion, the central bone fragment was displaced anteriorly at the fractured part, so a blocking k wire was inserted, but after repositioning, it was inserted again, but anterior dislocation again. The posterior part of the fracture was greatly crushed, and the doctor decided that the t2 alpha tibial nail could not maintain the reduction position, so it was changed to external fixation. Doctor's comment: the shape of the nail did not match the shape of the patient's bone. The bone quality was too weak. The plate will be fixed at a later date.
 
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Brand NameTIBIAL NAIL T2 ALPHA TIBIA 12X255MM
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10953268
MDR Text Key219978838
Report Number0009610622-2020-00830
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K191271
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 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2341-1225S
Device Catalogue Number23411225S
Device Lot NumberK0837BC
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 Received01/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2020
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: 12/05/2020 Patient Sequence Number: 1
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