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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 95MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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STRYKER GMBH STANDARD LAG SCREW OMEGA 95MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Catalog Number 33625095
Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.Device remains implanted.
 
Event Description
The customer reported that problems were encountered with the final turn of the lag screw inserter.The bone was hard and the surgeons had tapped to account for this.When measuring for the lag screw they had taken 5 off the measurement and therefore over reamed.When trying to turn the lag screw handle parallel to allow the plate to pass over the lag screw and sit onto the near cortex, the lag screw implant sheared off the insertion device and became bent/twisted.This meant it was then impossible to remove the lag screw and it had to be manipulated to allow the plate to pass over the top of it and into place.The operation was completed and it added around 1 hour to the operating time.No pieces fell into the wound.The lag screw was already inserted when the issue was discovered.The decision was made that it would be clinically safer to leave the screw in situ rather than remove it.The customer reported that the lag screw inserter is functional.The patient¿s bone quality was good, hence the reason the surgeon tapped the bone before he inserted the lag screw.The patient had a general anaesthetic and a regional block so no additional analgesia was needed.However the patient was anaesthetised for longer than would normally be necessary for this type of procedure.
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Unfortunately the x-rays do not reveal any damages.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
The customer reported that problems were encountered with the final turn of the lag screw inserter.The bone was hard and the surgeons had tapped to account for this.When measuring for the lag screw they had taken 5 off the measurement and therefore over reamed.When trying to turn the lag screw handle parallel to allow the plate to pass over the lag screw and sit onto the near cortex, the lag screw implant sheared off the insertion device and became bent/twisted.This meant it was then impossible to remove the lag screw and it had to be manipulated to allow the plate to pass over the top of it and into place.The operation was completed and it added around 1 hour to the operating time.No pieces fell into the wound.The lag screw was already inserted when the issue was discovered.The decision was made that it would be clinically safer to leave the screw in situ rather than remove it.The customer reported that the lag screw inserter is functional.The patient¿s bone quality was good, hence the reason the surgeon tapped the bone before he inserted the lag screw.The patient had a general anaesthetic and a regional block so no additional analgesia was needed.However the patient was anaesthetised for longer than would normally be necessary for this type of procedure.
 
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Brand Name
STANDARD LAG SCREW OMEGA 95MM LENGTH
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8729116
MDR Text Key149174758
Report Number0008031020-2019-00725
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07613327093032
UDI-Public07613327093032
Combination Product (y/n)N
PMA/PMN Number
K955306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Catalogue Number33625095
Device Lot NumberB88132
Was Device Available for Evaluation? No
Date Manufacturer Received07/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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