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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1796-5040S
Device Problems Difficult or Delayed Positioning (1157); Device Difficult to Setup or Prepare (1487)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Customer reported the following event: "when installing gamma nails, it is impossible to insert the distal screw through the nail.After several attempts to change the screw, the screw head is damaged but looks different from the new one as well as the screw pitch.The second is inserted without any difficulties".
 
Event Description
Customer reported the following event: "when installing gamma nails, it is impossible to insert the distal screw through the nail.After several attempts to change the screw, the screw head is damaged but looks different from the new one as well as the screw pitch.The second is inserted without any difficulties".
 
Manufacturer Narrative
Correction: refer to d10/h3.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.Device disposition is unknown.
 
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Brand Name
LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9387576
MDR Text Key191811531
Report Number0009610622-2019-00945
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540399731
UDI-Public04546540399731
Combination Product (y/n)N
PMA/PMN Number
K032579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1796-5040S
Device Catalogue Number17965040S
Device Lot NumberK077CC3
Was Device Available for Evaluation? No
Date Manufacturer Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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