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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE LAG SCREWDRIVER GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL U-BLADE LAG SCREWDRIVER GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1320-0310
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/08/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
During gamma3 surgery, the tip of the u-lag screw driver broke.It was recognized after surgery on x-rays.The tip was left in the patient.At the time the report was made it was noted the removal surgery would be performed the next week.
 
Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the device received shows traces of intense and frequent usage.The peg at the tip of the driver is completely broken off.The broken peg is not available for evaluation.The remnant peg shows typical signs of a forced, ductile breakage due to overload with evident material displacement.This indicates intense usage of the lag screwdriver with high torque application.It was manufactured in 2009, so it can be said that it had performed its function in the previous surgeries as intended without any reported failure.Since this has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿always treat the instrument carefully to avoid surface damage or alterations to the geometry.The stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ based on investigation, the root cause was attributed to a normal wear related issue.The u-blade lag screwdriver was manufactured in 2009, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.If any further information is provided, the complaint report will be updated.
 
Event Description
During gamma3 surgery, the tip of the u-lag screw driver broke.It was recognized after surgery on x-rays.The tip was left in the patient.At the time the report was made it was noted the removal surgery would be performed the next week.
 
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Brand Name
U-BLADE LAG SCREWDRIVER GAMMA3
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key12093060
MDR Text Key259185874
Report Number0009610622-2021-00582
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540377845
UDI-Public04546540377845
Combination Product (y/n)N
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1320-0310
Device Catalogue Number13200310
Device Lot NumberK428450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Date Manufacturer Received09/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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