MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L36MM; PLATE, FIXATION, BONE

Catalog Number	661436
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that, during a primary procedure on a right tibia, a drill bit broke, and a screw broke during implantation.The proximal tibia plate became damaged.The screw was removed.The surgery was completed using another kit.There was a surgical delay of approximately 5-10 minutes.No adverse consequences were reported.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L36MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8474896
• Report Number: 0008031020-2019-00343
• Device Sequence Number: 1783991
• Product Code: HRS
• UDI-Device Identifier: 07613252580393
• UDI-Public: 07613252580393
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 661436
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR