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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM PLATE, FIXATION, BONE

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STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 627638
Device Problems Break (1069); Difficult to Remove (1528); Material Protrusion/Extrusion (2979)
Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Event Date 07/13/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Hospital policy.
 
Event Description
This pi is for removal of three screws and screwdriver breakage. One screw was protruding through (i. E. Breaking) patients' skin in a plate/ screw construct. The first screw stripped and remained in patient, second screw removed without incident. The shaft of the screwdriver broke when attempting to remove the third screw. Patient's bone quality unknown. Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
 
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Brand NameDISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7756194
MDR Text Key116206596
Report Number0008031020-2018-00547
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123964
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number627638
Device Lot NumberUNKNOWN
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 Received09/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/07/2018 Patient Sequence Number: 0
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