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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965040S
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2017
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was discarded.
 
Event Description
It was reported that during primary surgery when physician used a screw depth gauge to select a screw, it was hard to use. Surgeon believes due to that he chose incorrect length screw.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6541851
MDR Text Key74498530
Report Number0009610622-2017-00128
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number18965040S
Device Lot NumberK0D4561
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 Received04/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2014
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: 05/03/2017 Patient Sequence Number: 1
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