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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LOCKING SCREW, T8 FULL THREAD, 2.4MM/L14MM; PLATE, FIXATION, BONE
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LOCKING SCREW, T8 FULL THREAD, 2.4MM/L14MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 656014
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
It was reported that the screw wouldn't lock in the plate, so the surgeon decided to use another screw.The second screw was successful.The failed screw was damaged, but no details about the damage have been provided.The procedure was completed successfully, with no adverse consequences to the patient.No clinically significant delay in treatment has been reported.
 
Event Description
It was reported that the screw wouldn't lock in the plate, so the surgeon decided to use another screw.The second screw was successful.The failed screw was damaged, but no details about the damage have been provided.The procedure was completed successfully, with no adverse consequences to the patient.No clinically significant delay in treatment has been reported.
 
Manufacturer Narrative
D9 / h3 updated to indicate device was not returned.The reported event that an unknown variax2 screw was alleged of issue ¿implant - insertion impaired¿ could not be confirmed, since the device was not returned and as the received picture is not sufficient to make an evaluation.The device inspection was not possible as the product was not returned for investigation.A potential non-conformity report was nonetheless initiated to address this event.The comprehensive root cause analysis of the potential ncr included a surface and microstructure analysis as well as nano-indent hardness measurement of variax1 and variax2 screw samples by the fraunhofer institute on behalf of stryker.Further internal investigation efforts were focusing on the anodization color difference between variax1 and variax2 screws.Significant differences between the screws which could result in the reported complaints have not been revealed in either fraunhofer or stryker investigations.Excessive in-house handling and bench testing with variax2 screws from various manufacturing batches showed that locking is achieved as intended.The desired increase in torque indicating to the customer that the screw is locking in the plate, can be confirmed.Considering the information given and based on the above investigations a root cause of the reported event could not be determined.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.If any further substantial information is provided, the investigation report will be updated.H3 other text : device disposition is unknown.
 
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Brand Name
LOCKING SCREW, T8 FULL THREAD, 2.4MM/L14MM
Type of Device
PLATE, FIXATION, BONE
MDR Report Key12333523
MDR Text Key266963690
Report Number0008031020-2021-00367
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327068344
UDI-Public07613327068344
Combination Product (y/n)N
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number656014
Device Catalogue Number656014
Device Lot Number1000438631
Was Device Available for Evaluation? No
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age64 YR
Patient Weight63
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