MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 7MM X 23MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number 234-010-161

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

The device manufacture date is not known at this time.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the screw broke and part of screw was left inside the patient.

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: "investigation findings are: minimal information has been provided relating to the screw breakage complaint.Warnings and precautions, including prevention of screw breakage are stated in the instructions for use.No medical intervention was required.Surgery was completed successfully.No delay in surgery.If the tapped depth is not deep enough, the bottom of the screw stays stationary and the peak (top half) of the screw continues to twist causing breakage.The suspected root causes are user error in method used- if the tapped depth is not deep enough, the bottom of the screw stays stationary and the peak (top half) of the screw continues to twist causing breakage." manufacture date is not known.

Event Description

It was reported that the screw broke and part of screw was left inside the patient.

• Brand Name: PKG. 7MM X 23MM 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 Key: 8814078
• MDR Text Key: 151840441
• Report Number: 0002936485-2019-00303
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 15060155710249
• UDI-Public: 15060155710249
• Combination Product (y/n): N
• PMA/PMN Number: K003641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 234-010-161
• Device Catalogue Number: 234-010-161
• Device Lot Number: 0917PH298165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other