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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X300 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X300 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1822-1130S
Device Problems Separation Failure (2547); Misassembly by Users (3133)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
It was reported the nail was attached to the handle backwards and would not come off.
 
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Brand NameTIBIAL NAIL, STANDARD T2 TIBIA Ø11X300 MM
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 Key12590478
MDR Text Key275180616
Report Number0009610622-2021-00742
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1822-1130S
Device Catalogue Number18221130S
Device Lot NumberK0B9164
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2018
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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