MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 11MM X 35MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-179
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke and some parts of the screw were left in the joint.
Additional 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 or Problem Description
It was reported that the device broke and some parts of the screw were left in the joint.
Additional 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 or Problem Description
It was reported that the device broke and some parts of the screw were left in the joint.

• Brand Name: PKG, 11MM X 35MM STRYKER BIOSTEON SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9120592
• Report Number: 0002936485-2019-00425
• Device Sequence Number: 19590954
• Product Code: HWC
• UDI-Device Identifier: 15060155710331
• UDI-Public: 15060155710331
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K003641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 234-010-179
• Device Catalogue Number: 234-010-179
• Device Lot Number: BS190201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 08/12/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 01/14/2020; 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other