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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
Model Number 1896-5040S
Device Problems Material Fragmentation (1261); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Customer reported that : "during the removal of the titanium nail installed on (b)(6) 2019, a spring appears next to the titanium screw corresponding to the thread that has come loose. " additionally reported: procedure completed successfully. No patient consequences. Delay : 5min, time to determine where this metal piece came from no other medical intervention. Spring came from locking screw. Removal of the nail within the consolidation period ((b)(6) patient, nail installed on (b)(6) 2018).
 
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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
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 Key9748377
MDR Text Key191577377
Report Number0009610622-2020-00061
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032244
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 04/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1896-5040S
Device Catalogue Number18965040S
Device Lot NumberK0CAAF1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2018
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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