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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 11MM X 35MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE
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STRYKER ENDOSCOPY-SAN JOSE PKG, 11MM X 35MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE Back to Search Results
Model Number 234-010-179
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that the device broke and some parts of the screw were left in the joint.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: screw broke.According to biocomposites: "feedback evaluation: it has been deduced that the "nail" is referencing the driver shaft.It states " at the time of passing the sliding screw through the nail does not advance" this sounds like the screw is not being driven into the bone, meaning the tapped hole is not wide/deep enough.Also " he specialist takes the decision to remove the nail and prove that it happens with the screw, it is visualized that the sliding screw is stuck in the nail after passing the threaded part" if the incorrect driver size has been used, this will have an effect on the performance of the device, as stated in the instructions for use.A new device was used to complete the surgery.No medical intervention was required.Some parts of the screw were left in the patient.Surgery was completed successfully.Feedback conclusion: user error.Please refer to the instructions for use for guidance on correct drivers for your screw size."inappropriate sizing may result in screw breakage due to excessive torque being applied.It is essential that the screwdriver and screw maintain an in-line orientation".Manufacture date is not known.
 
Event Description
It was reported that the device broke and some parts of the screw were left in the joint.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: screw broke.According to biocomposites: "feedback evaluation: it has been deduced that the "nail" is referencing the driver shaft.It states " at the time of passing the sliding screw through the nail does not advance" this sounds like the screw is not being driven into the bone, meaning the tapped hole is not wide/deep enough.Also " he specialist takes the decision to remove the nail and prove that it happens with the screw, it is visualized that the sliding screw is stuck in the nail after passing the threaded part" if the incorrect driver size has been used, this will have an effect on the performance of the device, as stated in the instructions for use.A new device was used to complete the surgery.No medical intervention was required.Some parts of the screw were left in the patient.Surgery was completed successfully.Feedback conclusion: user error.Please refer to the instructions for use for guidance on correct drivers for your screw size."inappropriate sizing may result in screw breakage due to excessive torque being applied.It is essential that the screwdriver and screw maintain an in-line orientation".
 
Event Description
It was reported that the device broke and some parts of the screw were left in the joint.
 
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Brand Name
PKG, 11MM X 35MM STRYKER BIOSTEON SCREW
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9120592
MDR Text Key163208498
Report Number0002936485-2019-00425
Device Sequence Number1
Product Code HWC
UDI-Device Identifier15060155710331
UDI-Public15060155710331
Combination Product (y/n)N
PMA/PMN Number
K003641
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number234-010-179
Device Catalogue Number234-010-179
Device Lot NumberBS190201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Date Manufacturer Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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