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

Catalog Number	234-010-161
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the device broke in the joint.Multiple attempts were made to gather more information, however no new information was received.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: screw broken.According to biocomposites: feedback evaluation: 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, it was cause the bottom of the screw to stay stationary and the peak (top half) of the screw to continue to twist causing breakage.Feedback conclusion: user error in method used- if the tapped depth is not deep enough, it was cause the bottom of the screw to stay stationary and the peak (top half) of the screw to continue to twist causing breakage.The device manufacture date is not known.
Event or Problem Description
It was reported that the device broke in the joint.Multiple attempts were made to gather more information, however no new information was received.

• Brand Name: PKG. 7MM X 23MM 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: 8783060
• Report Number: 0002936485-2019-00291
• Device Sequence Number: 1668066
• Product Code: HWC
• UDI-Device Identifier: 15060155710249
• UDI-Public: 15060155710249
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/13/2019

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 Catalogue Number: 234-010-161
• Device Lot Number: 0518PH165161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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